Dodgy lawmaking in the Indian Parliament – Part 2

The following is the transcript of the video published here: https://www.youtube.com/watch?v=yKU8qA4ClZU&ab_channel=Policytalk

  • Go to Infographic 2: Table of rules, guidelines and traditions broken by the BJP government

Priyanka: Hi, we are Priyanka and Rishika, and we are back with a follow-up of our earlier video on how crucial laws were amended without regard to established parliamentary processes in the monsoon session of the Indian parliament. This session was held in July and August, last year.

Rishika: You can check out our previous video, linked in the description below, to understand how amendments brought to crucial environmental and health-related laws in the monsoon session were problematic – both in terms of what the amendments entailed and the undemocratic manner in which they were rushed through. They relate to the Forest Conservation Act, the Biological Diversity Act and the Jan Vishwas Act.

Priyanka: Today, we want to go a little deeper. Our research in the past few months, and the proceedings of the parliamentary special session in September and the winter session in December, gave us further insights into how our parliament works. 

What we found is that Indian parliamentary processes are not codified well enough to uphold democratic principles. This means that lawmakers didn’t always translate parliamentary processes into hard-and-fast rules, with a legal basis. Instead, several important processes remained optional — in the form of guidelines from the law ministry and traditions, followed merely by custom.

Rishika: The assumption behind not codifying all parliamentary processes seems to have been trust that MPs would use the principles of democracy while interpreting guidelines and traditions.

And MPs have honoured this trust often enough. For instance, requiring public consultation before introducing important bills into the parliament has never been a rule. And yet, historically, ministries have conducted these consultations because it is a part of democratic functioning.

Priyanka: So, what do these parliamentary rules, guidelines and traditions do? They tell MPs how to carry out important functions of the parliament, such as law-making and  seeking information and accountability during question hour. 

This brings us to the core point of our current episode: the ruling BJP government has been breaking rules,and interpreting long-standing guidelines and traditions to further its own interests. This has led to several laws being rushed through both houses of parliament  without scrutiny.

 Rishika: For instance, look at this part of the lawmaking process, where the nodal ministry, which is the ministry that drafts the law, is introducing a draft law into Parliament. A rule that governs this part is for the nodal ministry to circulate the draft among MPs two days before introduction. 

Like we said, circulation to MPs two days before introduction into parliament is a hard and fast rule. Its legal basis comes from the fact that it is made under Article 118 of the Indian Constitution. 

Now focus here, where the parliament is sending a draft law for scrutiny to committees. This practice is merely a tradition. 

Traditions, as we said, are optional, because they are followed by custom. Even the practice of suspending a Question Hour only with the unanimous consent of MPs is a tradition. 

Finally, here the ministry is putting out the draft law for public consultation.  This is a guideline, described in a document called the Pre-legislative Consultation Policy.

As we mentioned earlier, this guideline is optional, but carries more weight than traditions, because it comes from the law ministry. Also, the Pre Legislative Consultation Policy says that if the nodal ministry wants to waive the policy, it must record its reasons in a note to the cabinet. 

We will share this table with you in the description of our video. You can view all parliamentary rulebooks, guidelines and commentary texts in the source section. 

Priyanka: Now, let’s start with the first step of the lawmaking process, which is when the nodal ministry decides to make or amend a law. This ministry can have various motivations for bringing in a new law or amending an existing one. 

It could be that a court judgement required the government to write or amend a legislation. For instance, the impetus for the Personal Data Protection Bill came from a landmark Supreme Court judgement which upheld the right to privacy as a fundamental right. As part of the judgement, the court also  told the government to write a data protection law.

There can also be a political agenda behind new bills. So for instance, the BJP in its 2019 election manifesto said they would abrogate Article 370, which gives a special status to Jammu and Kashmir. Then, after the BJP got re-elected, they brought in a bill to do exactly this. 

Anyway, regardless of motivation, the nodal ministry begins drafting a white paper that explains the background of the bill. Once prepared, the ministry sends the white paper to the legislative department under the law ministry which writes the draft law.  

Rishika: The draft law is then put out for public comments as recommended by the Pre-legislative Consultation Policy. This Policy was introduced in February, 2014. The thinking behind it was that new laws are often complex and contentious. So, it is important to build a consensus among stakeholders impacted by such laws while drafting them. This is what the policy aims to do.  

Among other things, this policy explains how public consultations should happen: the nodal ministry shouldn’t just publish a draft of the law, the policy says, but should also share it proactively with people and the draft must remain in public domain for at least 30 days. 

What’s more, the policy says, when the proposed legislation affects a specific group of people, take for instance the forest bill which affects forest-dwelling communities, it should be given wider publicity through print and electronic media. Other means to ensure wide circulation could include translations into local languages to ensure it reaches affected communities. 

Priyanka: The next step is where the nodal ministry considers the public comments and also consults with other ministries whose work could be impacted by the bill. In the case of the forest bill, the relevant ministries include the tribal affairs ministry, rural development ministry, and the road transport ministry. 

After this, the legislative department under the law ministry finalises the draft law. This is presented before the cabinet. If the cabinet approves it, the draft law is circulated to MPs before introduction in the parliament. 

Risihka: The circulation of the draft law among MPs is a very important step because MPs cannot knowledgeably discuss the bill before they have read it. 

Once the bill is in the parliament, it is sent to parliamentary committees for scrutiny. One reason for this step is that not every MP has the expertise to scrutinise the nitty gritties of technical laws. As Chakshu Roy from PRS Legislative Research, told us, and we quote:“when you have a discussion in a large chamber with multiple people sitting on a technical subject, the discussion is more at a broader level, maybe at a principled level, rather than at the nuts and bolts kind of level.” 

So, to have a nut-and-bolts kind of discussion, we need specialised committees.  

Secondly, MPs may not be comfortable voicing their views on the law in the public forum of the parliament, especially if these views don’t echo the stand taken by their party. They are far more likely to speak candidly, and prioritise public interest, if they have a confidential safe space to do so. 

Parliamentary committees serve both these purposes: they are made up of experts on the subject of the draft law, and the deliberations take place behind closed doors. 

After the parliamentary committee report is ready, it is presented before both houses of parliament along with the bill. MPs can use this report to debate on and vote on the bill. Once voting is complete, the bill moves on to the next house, and then to the president for approval. 

Priyanka: Now that we know how the lawmaking process works, let’s get into some examples of how the BJP flouted the rules, traditions and guidelines that govern this process. 

Rishika: Our first example has to do with the BJP flouting an important guideline, namely the Pre Legislative Consultation Policy. This happened during the monsoon session of 2023, when the BJP introduced the Forest Conservation Amendment bill. 

As we mentioned earlier, the Pre Legislative Consultation Policy helps in building a consensus on contentious bills that impact many people.

The Forest bill was one such bill, which made it easier to divert forest land by narrowing the legal definition of what a forest is. The impact of this bill on people is huge –  tribal communities who live in forests and draw their livelihood from forest resources would bear the brunt of it . 

So, if the policy was followed, the ministry would have done a thorough consultation with these communities and also other experts, like conservationists and environmental lawyers. This did not happen. 

And yet, no rules were broken, no laws were breached because the Pre legislative Consultation policy is only a guideline. 

The BJP government has flouted this policy elsewhere too. They failed to follow it while drafting two other laws, namely the Jan Vishwas bill and the Biological Diversity Amendment Amendment bill. 

The Jan Vishwas bill amended India’s key drug law, the Drugs and Cosmetics Act, to remove jail-terms for the manufacture of poor quality drugs.  

Such a decriminalisation impacts all Indians, who can be hurt from consuming poor-quality drugs. This means the government should have publicised the bill very widely and consulted expert groups, like health activists, while drafting the amendment. This didn’t happen.

As for the Biodiversity bill , it exempts certain persons (like those in the AYUSH industry) from sharing profits from accessing biological resources,, like herbs, and associated traditional knowledge, with local communities.  Since this directly affects such communities, the environment ministry should have consulted them on the provisions of the bill. This too did not happen.

Priyanka: Our second example is about the BJP flouting an important parliamentary rule, which requires draft laws to be circulated among MPs two days before introduction into the Rajya Sabha. 

The BJP flouted this rule while amending the National Capital Territory of Delhi Laws (Special Provisions) Second Act in the 2023 winter session of the Rajya Sabha. The goal of this amendment was to extend protection to unauthorised development, like colonies, slum dwellings, and schools – in and around Delhi — by three years. 

As we said earlier, this rule exists because MPs cannot knowledgeably discuss a draft law and vote on it unless they have had enough time to read through the law. Such circulation beforehand also allows MPs to vote against the introduction of draft laws into the parliament. There could be legitimate reasons to do this. 

For instance, let’s say a member wants to introduce a bill on a subject which is only on the state list of the Constitution. For example, police and public order are on the state list.

This means parliament may not have the power to make laws on these subjects – it is up to the state government to do so. MPs can cite this as a reason to block the law before introduction itself. 

The BJP has broken the rule on circulating bills before introduction earlier too.  A previous instance in which the BJP government completely sidestepped this rule was while introducing the Jammu and Kashmir Reorganisation Bill in 2019, a bill which sought to break the state of Jammu and Kashmir into two union territories. 

As Maansi Verma, a legislative policy expert at the parliamentary watchdog body Maadhyam writes, the BJP government did not even list this bill before introducing it into the Rajya Sabha on 5th August 2019, let alone circulate it two days in advance. The chairperson, Venkaiah Naidu, merely waived off the need for circulation, citing the urgency of the bill. 

Verma argues that this was a clear violation of parliamentary rules. Her reasoning? The rule only allows the Rajya Sabha chairperson to tweak the 2-day prior-circulation period to a shorter period, say 2 hours. It does not allow the chairperson to waive off circulation altogether, as the BJP did in both 2023, with the National Capital Territory bill and in 2019, with the J&K bill. 

Rishika: Our next example is about the tradition of sending bills to committees, for further scrutiny, after they are introduced into the parliament. There are two types of committees: one is called a Departmentally Related Standing Committee, which is constituted every year. We’ll refer to it as a Standing Committee from now on. 

The other is an ad hoc committee, called a Joint Parliamentary Committee (or a JPC). This  is created de novo, meaning it starts fresh, for the express purpose of scrutinising the bill. It also ceases to exist once the job is done.  And a longstanding tradition of the parliament has been that when a standing committee relevant to the topic of the bill exists, the bill is sent to that standing committee, rather than creating a new JPC.

The speaker flouted this tradition by sending the Forest bill to a JPC, when a Standing Committee for the purpose already existed, that is the Standing Committee on Science & Technology, Environment and Forests. 

This decision, to send the bill to a JPC instead of the standing committee ,was vigorously protested by Jairam Ramesh, former environment minister who chaired this standing Committee.

And the JPC (incidentally headed by a BJP MP) which assessed the forest bill ended up giving it a clean chit, with zero recommendations for changes. It did so despite receiving many objections from other ministries like tribal affairs and panchayat raj, some state governments from the northeast, and also conservationists, environmental lawyers and tribal groups.

Why are standing committees preferred to JPCs? For one thing, Standing Committees oversee particular ministries, and so have  more expertise on subjects related to that ministry.

As MP from Trinamool Congress Jawahar Sircar puts it, their members tackle issues related to this ministry day in and day out, some of the Standing Committee members have been on the committee for years, and have grilled the ministry several times earlier on similar themes. This means that Standing Committee members are likely to be familiar with the subject and the story behind the bill itself. 

Today, we have 24 such specialised Standing Committees, like a committee on “health and family welfare”, a committee on “petroleum and natural gas”, and a committee on “Science & Technology, Environment & Forests”. So, many bills introduced into the parliament will likely have a relevant standing committee. And the need to create a JPC arises only in some circumstances. 

According to Maadhyam’s Verma, these circumstances could include situations when the relevant Standing Committee gets held up with other duties, like scrutinising the annual reports of the ministry they are affiliated with. In other words, they simply may not have the time to deliberate on all bills in their area of expertise 

All experts we spoke to agreed, broadly, that when a Standing Committee relevant to the topic of the bill exists, then this standing committee is best placed to scrutinise the bill.

But this practice of sending bills to standing committees is only a tradition. It is not codified as a parliamentary rule. 

 The BJP government has sent several other bills to JPCs, when relevant standing committees exist including the Biodiversity bill. 

In fact, escaping scrutiny by any committee, and not just standing committees, has been a trend with the BJP since 2014. In the current 17th Lok Sabha and the previous 16th Lok Sabha, far fewer bills were referred to committees compared to earlier times. According to PRS Legislative Research, only 16% of the bills went to committees in the 17th Lok Sabha and 27% in the 16th. Now compare this to 60% in the 14th, 71% in the 15th lok sabha. 

Priyanka: Our final example has to do with the Question Hour. One of the important parliamentary rules is for the Question Hour to be held in every session, unless the speaker suspends it. 

This rule is accompanied by a longstanding tradition, that the Question Hour is only suspended with the unanimous approval of MPs. In other words, even if the speaker has the power to suspend the Question hour unilaterally, he or she has rarely done so. 

 Historically, the speaker has exercised this power of suspension without unanimous approval, only in unusual circumstances. One such circumstance was the 1975 emergency, a dark time for Indian democracy. 

Despite the existence of this tradition, in September last year, the BJP government suspended the question hour while calling for a special session of the parliament. A special session is one that is held outside of the conventional Budget, Monsoon and Winter Sessions. In its notice, the government said there wouldn’t be any question hour in both Lok Sabha and Rajya Sabha.

 No reasons were given for this decision and the unanimous consent of MPs was not taken.  

Why is the question hour important?It  is one of the few ways for the parliament to hold the government to account. As opposition MPs argued in a letter to the speaker when the BJP suspended the question hour earlier, “One of the main functions of Parliament in a democracy is to seek accountability from the executive on behalf of the people and Parliament. 

Questions are the most potent tools in that regard. 

There exists no other platform like the floor of the Parliament for the people to question the executive, through their representatives.” 

The last time the BJP suspended the question hour was in 2020. At that time, they cited an oddly flimsy reason – that due to the COVID pandemic, the parliament needed to keep the number of people in it to a bare minimum, and to maintain social distancing. 

The reason we call this justification flimsy is that the government proposed that a total of 33 bills be considered in the same session.  So, the Covid pandemic was a good enough reason for it to suspend question hour, but not good enough to hold back the bills they wanted to push.

Anyway, eventually, the Lok Sabha speaker allowed only written questions to be asked in that session, and no question hour was held.  

Rishika: The examples we discussed tell us why rules, traditions and guidelines are all equally critical to the functioning of the parliament. Yet, rules carry a greater weight. When they are broken, MPs can raise this issue with the speaker (this is called raising a point of order). 

They can even bring in a no-confidence motion against the chairman/ speaker of the house for not following rules. This is what 46 opposition MPs did after the passage of farm bills in 2020. 

Finally, MPs and citizens can even challenge the breaking of parliamentary rules in court, as AAP member Raghav Chadha did in 2023, when he was suspended from the Rajya Sabha. Raising these issues and challenging them in court would have been harder to do with guidelines and traditions. 

Priyanka: This is why it is important to turn crucial parliamentary processes, like sending bills to committees, into mandatory rules. In fact, a few experts (including Maadhyam) have come together to push for changes exactly like this. 

They have drafted a manifesto titled ‘People’s Demands to Make Parliament Great Again’, which recommends several such reforms. These reforms would allow MPs to hold  the executive accountable, and prevent further democratic backsliding. 
You can see the manifesto in the link below the video. It is also open to further public consultation.

Rishika: If you’re wondering why such reforms haven’t happened yet, a big reason is lack of political will. In one of her papers , Maadhyam’s Verma argues that it is not in the best interests of political parties – be it ruling parties or the opposition – to carry out such reforms. This is because the current vagueness tends to benefit whichever party is in power. And this is a status quo everyone wants to maintain. 

Priyanka: Is there any answer to this problem then? We think that change can come if citizens understand the need for parliamentary reforms and seek such reforms from their MPs. This was one big motivation for us to track these parliamentary sessions. 

Rishika: We were shocked to see the manner in which bills were pushed through. Most of the time this happened when the opposition was not in the room, because the MPs either boycotted the session to highlight concerns about Manipur, or were suspended en masse. 

We wanted to understand what made it so easy for the BJP government to pass amendments to crucial legislations, without wider deliberation – either with the public or with opposition MPs. And we found that parliamentary processes were so poorly codified that members could break them with almost no consequences. This is more so in cases where the ruling government enjoys a strong majority in both houses of parliament. Properly codified processes would make it easier to uphold principles of a deliberative democracy where the majority cannot run roughshod over the minority. 

And there is reason to be optimistic: reforms for better parliamentary functioning have been happening over the years, even if slowly.

Priyanka: Our hope, with this video, is to focus on the urgent need for such reforms and for citizens to push for them. The people who have the greatest stake in parliamentary reforms are, after all, not political parties, but us, the common voters. The codification of parliamentary procedures, then, is a cause every one of us must fight for. 


Thanks to our sources: 

  • Maansi Verma, founder and legislative policy researcher at Maadhyam
  • Chakshu Roy, legislative and civic engagement initiatives at PRS Legislative Research
  • Itika Singh, program manager at PRS Legislative Research
  • Jawahar Sircar, Rajya Sabha MP, member of All India Trinamool Congress 
  • Video edits and graphics: Yash Nene
  • Sansad image illustration: Paramvir Singh

Flowchart of the lawmaking process

Table of rules, traditions and guidelines broken by the BJP government

RulesGuidelinesTraditions
Hard and fastOptional, but recommendedOptional
Eg: Circulate draft laws among all MPs before introducing into the parliamentEg: Public consultation Eg: Sending draft laws to parliamentary committees, Requiring unanimous consent of all MPs to suspend Question Hour
Eg of rule violation: 

1) National Capital Territory of Delhi Laws (Special Provisions) Second (Amendment) Bill 
2) J&K Reorganisation Amendment Bill
Eg of guideline violation: 

1) Forest Conservation Amendment Bill
2) Jan Vishwas Bill
3) Biodiversity Amendment Bill
Eg of tradition violation: 

1) Forest Conservation Amendment Bill
2) Biodiversity Amendment Bill
3) Only 16% bills sent to standing committees since 2019
4) Special Session 2023
5) Monsoon Session, 2020
Source: Directions by Speaker, Lok Sabha and  Rules of Procedure and Conduct of Business in Lok Sabha, Directions by the Chairman, Rajya SabhaRules of Procedure and Conduct of Business in the Rajya SabhaSource: Pre Legislative Consultation PolicySource: Practice and Procedure of Parliament by Kaul and Shakdher
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How regulatory inspections happen in India

(Accompaniment to Can Rajeev Raghuvanshi solve India’s drug quality woes?)

When an inspector from a state regulatory agency, say Himachal Pradesh, inspects a plant, their goal is typically to check whether the plant is following all Good Manufacturing Practices (GMP), which are codified in Schedule M of the Drugs and Cosmetics Act.

If they find violations of GMP, these are classified as major or minor violations. When there are multiple major violations, and the inspector believes this impacts the quality of the products made in the plant, they have a range of potential actions to choose from.

They could either cancel the plant’s licence to manufacture a single product or multiple products. Alternatively, if the offence is minor, they could suspend the licence for several days or months. They could also, technically, cancel or suspend the plant’s licence to manufacture all products. A cancellation of all licences effectively means the plant is shut down permanently.

Before issuing such licence cancellations or suspensions, however, the Drugs and Cosmetics Rules require the inspector to issue a show-cause notice. This notice asks the manufacturer to explain why the licence should or should not be cancelled/suspended. If the manufacturer gives a satisfactory answer, the regulator may choose not to proceed with the cancellation/suspension.

The inspector also has another tool in their toolbox if they think the plant poses an immediate threat to customers. Under Rule 85(2) of the Drugs and Cosmetics Rules, they can ask the manufacture to stop making some products immediately, until further orders. Doing this does not require a show-cause notice to be issued. This is called a Stop Manufacturing Order, and can be used for individual products, or all products of a plant. Until the regulator revokes this order, the manufacturer cannot resume manufacturing.

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Can Rajeev Raghuvanshi solve India’s drug quality woes? (A Negative Nancy take)

In the past weeks, two media articles had high praise for Drug Controller General of India Rajeev Raghuvanshi’s moves to reform the Indian pharma industry. The first, for News18.com, spoke about how Raghuvanshi’s bold moves were “rebuilding the pharmacy of the world”. The second, for ET Prime, took a similar tone.

Between them, the articles described how Raghuvanshi helmed a series of risk-based inspections of manufacturing units, introduced a much-delayed new Schedule M, is planning a digital regulatory ecosystem, inaugurated a QR code scheme to ensure the authenticity of drugs, and oversaw a new testing regime under which all exported cough-syrup would be certified for quality by government labs. Both articles said these moves sent strong signals to the pharma industry that it couldn’t neglect quality anymore.

A layperson reading these articles could leave thinking Raghuvanshi’s actions are unprecedented and far-reaching. And that they represent a major inflection point for Indian pharma quality.

I would disagree with that layperson.

And this blog post explains why.

First, Raghuvanshi’s actions are not as unprecedented as both articles suggest. Almost every action he has taken was in the works much before he took over as DCGI in 2023. The health ministry first published the draft Schedule M in 2018. It announced a plan to implement mandatory QR/bar-codes for the top 300 brands in India in June 2022.

State regulators have implemented regulatory information systems of all shapes and colours before, including the XLN database. In 2016, Kundan Lal Sharma, then joint secretary in the health ministry kickstarted the process of risk-based inspections.

Bottomline: none of these actions are truly new.

What has also happened before is pharma-industry pushbacks, leading to a watering-down of these moves. The industry resisted the implementation of Schedule M till today – in fact it continues to do so. A portion of the XLN India database, which captures substandard drug data, is today used by only five states. Risk-based inspections were discontinued after 2017, possibly due to the industry resistance.

In other words, bold regulatory actions have a way of getting rolled back.

Second, I don’t know if a single individual, let alone a DCGI, whose tenure is limited to 3 years, and who has no real independence from the health ministry, can take truly far-reaching actions. A DCGI certainly cannot compel state regulators to do anything which the Drugs & Cosmetics Act doesn’t require the latter to do. Nor can a DCGI improve funding for CDSCO and state regulators, which has been among the biggest problems hamstringing these agencies.

Finally, the DCGI or CDSCO cannot even amend the Drugs and Cosmetics Act and Rules, many of which are directly responsible for Indian quality problems.

So, what happens when Raghuvanshi’s tenure ends in February 2025? Is there a long-term strategy behind his bold moves? Is the Drugs and Cosmetics Act being amended in ways that can bring about lasting change? Or are Raghuvanshi’s actions, and the accompanying media hype, just another example of the BJP responding to a crisis by running PR campaigns?

I believe the current DCGI could push the moves he did, because he took charge at a time when the BJP government was hit by a massive reputational crisis. The crisis began with media criticism of hurried Covid drug and vaccine approvals by CDSCO in 2020. When the government tried to brush off these critics as Negative Nancies/Cassandras/Macaulay putras etc., the Gambian cough-syrup adulteration came to light.

When BJP health minister Mansukh Mandaviya valiantly tried to paint even the Gambian incident as a foreign conspiracy against the Indian industry, more bad news came. The Uzbekistan cough-syrup adulteration occurred, followed by a similar case in Cameroon, all traced to Indian manufacturers. It was impossible to brush away this-pile up of bad news as mere one-offs anymore. 

This series of unfortunate events forced the BJP government’s hand. The general elections are barely months away. The government needed a way to fix their image, and they were willing to give a free reign to any DCGI who could help there.

Raghuvanshi was in the right place, at the right time, and has the right skills. And to his credit, he is doing, mostly, the right thing.

But is he really “rebuilding the pharmacy of the world” or “transforming” CDSCO, as the congratulatory media claims? I’d want evidence of a long-term strategy before I start popping the champagne, thank you.

To explain further, let me break down some of Raghuvanshi’s “bold” actions, how they have been attempted before, and why they failed to make lasting change.

Action 1: Raghuvanshi kickstarted risk-based inspections, and shut down poorly functioning plants.

Since March 2023, multiple media articles talked of CDSCO and state regulators conducting a series of inspections of manufacturing plants. The plot of these articles is as follows: CDSCO has identified a set of plants, based mainly on their track-record of producing substandard drugs. And they have begun joint inspections, together with state regulators, of these high-risk plants. This is a strategy known as “risk-based” inspections.

This was good news, of course.

But was it really all it was cracked up to be?

The idea of risk-based inspections is to help regulators prioritise the oversight of those plants that are most likely to harm consumers, given that regulators frequently do not have enough manpower to keep an equally sharp eye on all plants. This document from the PICS (the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme) tells regulators how to decide which plants to prioritise.

It asks them to look at two factors:

  1. The intrinsic risk of the plant: Some plants make products that have complex manufacturing processes, leading to greater quality failures. These include sterile drugs and biological drugs, like insulin. These get a high intrinsic-risk score under the PICS framework. The framework also gives a high score to those plants that make essential drugs that are not made by any other manufacturer. So, for example, the only maker of a particular vaccine in a country also gets a high intrinsic-risk score.
  2. The compliance risk of a plant: The compliance risk of a plant is considered to be high when regulators have previously identified critical or major deficiencies in Good Manufacturing Practices at a plant. In comparison, plants where inspectors found only minor or no deficiencies get lower scores.

Based on a combination of intrinsic and compliance scores, PICS advices, regulators must decide how often to inspect plants. The plants with the highest risk ratings need to be inspected at least once a year or less, while the lowest rated plants need to be inspected at lower frequencies, say, once in three years.

Readers should know that risk-based inspections were an urgent need for India much before Raghuvanshi came along. This is because India has some 10,000 manufacturing units that are overseen by 36 regional regulators, and 1 central regulator. All of these regulators lack enough staff  to inspect these plants often enough.

How often is often enough? Well, Rule 52(1) of the Drugs and Cosmetics Rules requires every inspector to audit every manufacturing unit in their area atleast once a year.

The reality is very different. For instance, I reported in 2022 that the Karnataka drug regulator and CDSCO did not jointly inspect IAHVB, the only manufacturing plant for the Kyasanur Forest Disease vaccine in all of India, for atleast five years. Note that vaccines are both sterile and biological products, which increases their intrinsic-risk score under PICS criteria.

The Drugs and Cosmetics Act recognises the complexity of vaccine-manufacture, which is why it requires vaccine plants to be inspected jointly by the CDSCO and state regulators. The idea is that most state regulators do not have the skills to oversee sterile biological products.  

Yet, as I reported, IAHVB was allowed to make the Kyasanur Forest Disease vaccine for several years with no CDSCO oversight. How did this happen despite the existence of rule 52(1)? When I asked the Karnataka drug regulator this, they pointed to a 2017 amendment in the Drugs and Cosmetics Act, that allows a manufacturer’s licence to be renewed even if the plant is never inspected during the licence period (typically five years).

This amendment is worth getting into, to understand how our health ministry makes regulation. Until 2017, Rule 79 of the Drugs and Cosmetics Rules did not allow a licence to be renewed unless it was inspected atleast once during its licence period. Since regulators don’t have enough staff to fulfil this requirement, this put manufacturers at risk of having their licences cancelled.

The 2017 amendment fixed this problem for everyone. It allowed a regulator to renew the plant licence as long as it had conducted either one inspection in three years, or inspections on a risk-basis.  In other words, state regulators and the central regulator were free to skip inspections for years together, as long as they considered the plant to be low risk. And this wouldn’t jeopardise plant licences either, a win for the industry. This is what led to the crazy situation of the Kyasanur Forest Disease vaccine manufacturer functioning for years with no inspections, well after the vaccine stopped working.

It is against this background that Raghuvanshi kickstarted risk-based inspections in 2023. State regulators were allowing many plants to get away with close to zero oversight. Customers were getting dangerous and ineffective products. And risk-based inspections had already been attempted once before, only to be stopped.

In other words, what Raghuvanshi did was the minimum any DCGI should have been doing.   

Now that that’s out of the way, a look at how CDSCO and Raghuvanshi carried out these risk-based inspections.  

First, consider the PICS criteria to estimate the risk of plants: if CDSCO was following these criteria to identify high risk plants, all biological and vaccine plants, serum plants, plants making sustained-release drugs, large plants supplying to multiple markets and customers etc would receive high intrinsic-risk ratings. Further, any plant which got bad ratings in previous inspections would get high compliance-risk ratings.

Now, let’s look at what CDSCO actually did. According to this November 2023 News18 article, CDSCO relied on the following data sources to identify high-risk plants:  a drug quality survey conducted by the National Institute of Biologics (NIB) almost seven years ago, reports from CDSCO and state regulators’ monthly random-sampling programs, reports from international regulatory agencies and information gathered through intelligence.

Using this data, CDSCO identified those plants that had manufactured more than a certain cut-off number of substandard drugs and shortlisted them for inspection. In addition, News18 reported, they also added India’s 130 oxytocin injectable manufacturers to the tally. (It is not very clear why CDSCO considered only oxytocin manufacturers to be high risk, when hundreds of other drugs are also sold as sterile injectables).  

Put together, CDSCO shortlisted 203 plants for the first phase of risk-based inspections. It isn’t clear how many other phases there are, and how many plants will be inspected in total (don’t forget, India has 10,000 manufacturing plants).

Subsequent media articles, published after March 2023, quoted other conflicting numbers, suggesting that CDSCO shortlisted more plants in the next couple of phases. By January 2024, CNBC TV 18 reported, CDSCO had jointly inspected upto 254 plants. I have summarised all media numbers in the table below:

Summary table from media reports on risk-based inspections

 SourceNews 18MintRajya SabhaPharmabizETCNBC TV18
1Linkhttps://shorturl.at/hkZ29https://shorturl.at/sDFO5https://shorturl.at/tyCDZhttps://shorturl.at/quvyPhttps://shorturl.at/ilMX1https://shorturl.at/dquLR
2AuthorH. ChandnaP. SharmaHealth ministryS. NautiyalT. ThackerT. Jaipuria
3Time Mar 2023Mar 2023  August 2023Oct 2023 Nov 2023Jan 2024
4# plants selected for inspection203203Not mentionedUnclearNot mentionedNot mentioned
5# plants inspected until time in 4th row767616274237254
6# plants given show-cause notice2626143No number given179Not mentioned
7# plants that lost product licences3No number given66Not mentionedNo number givenNot mentioned
8# told to stop manufacturingNot mentionedNot mentioned403976Not mentioned
9# plants that lost mfg licence1818 Not mentioned15Not mentioned
10# plants given “warning letters”Not mentionedNot mentioned21Not mentioned35Not mentioned
11# plant owners against whom FIR lodgedNot mentionedNot mentioned1Not mentionedNot mentionedNot mentioned

What can one take away from the above (rather conflicting) data?

First, the criteria used by CDSCO to shortlist high-risk plants looks inadequate and unclear compared to PICS criteria. Why didn’t CDSCO consider any other sterile drug manufacturers, apart from oxytocin, if all sterile drug manufacturers have high levels of risk? And where are the biological makers, and the makers of sustained-release drugs?

India’s quality problems with sterile drugs are well documented. Within the last few years, eye drops made by a Chennai company blinded patients in the USA, while cancer injectables from a Maharashtra company were linked to the deaths of children in Colombia. So, why oxytocin alone?

In addition to oxytocin makers, CDSCO also considered a manufacturer’s track record of making substandard drugs for risk-assessments, and this method could have identified a few sterile drug manufacturers. But the problem here is that Indian regulators have historically been very poor at testing sterile drugs in their random sampling programs, as authors Dinesh Thakur and Prashant Reddy wrote in The Truth Pill.

Further, I reported in 2021 that several state regulators didn’t even have the equipment to do key quality tests for sterile drugs, such as sterility and bacterial endotoxins. So, sterile drugs simply don’t figure often enough in Indian substandard-drug lists. The same would be true for biologicals.

Be that as it may, how efficiently did the CDSCO joint inspections cover the plants that were shortlisted?  If one looks at the speed alone, inspecting roughly 300 plants in around one year is a glacial pace. 300 is a tiny fraction of the total number of Indian plants. Ganadhish Kamat, a quality expert who retired as global quality head at Dr Reddy’s Labs, pointed out that at this rate, the CDSCO will take over 30 years to inspect all of India’s 10,000+ manufacturers. That’s slow.

A final problem I have with CDSCO’s media-blitz on risk-based inspections is the confusing details around the scheme. The regulator never put out any official press release, choosing instead to leak conflicting information to the media. Click here to see how a typical regulatory inspection takes place, and the range of actions a regulator can take under the Drugs and Cosmetics Act.

Against this background, one media article says 18 of the 203 inspected plants were found to be so dysfunctional that they lost their licence to manufacture. It doesn’t tell the reader whether this was a licence suspension (for a limited period) or a cancellation (permanent); nor does it tell them whether the plant’s products were recalled. In November, an ET article dials back on these numbers, claiming licences of only 15 plants were cancelled, but that 76 got stop manufacturing orders.

What happened after the stop manufacturing orders were issued? This data is important, because manufacturers typically don’t take such orders lying down. Digital Vision, the Himachal-based company whose cough syrup was linked to around a dozen deaths in Jammu in 2019, challenged the stop manufacturing order issued by the state regulator in the HP High Court, and is back in business again. Given that this happens often enough, shouldn’t consumers be told the status of these 76 plants?

Finally, CDSCO seems to be using made-up words in updates on risk-based inspections. In an August 2023 response to a Rajya Sabha question on the status of risk-based inspections, the health ministry claimed that the CDSCO issued “warning letters” to 21 plants. The term “warning letters” does not even exist in the Drugs and Cosmetics Act, and is in-fact a legal term used by the American regulatory agency, the USFDA.

As I explain here, when a plant is found to be in a poor state of functioning, the CDSCO can either issue a show-cause notice or a stop manufacturing order. The show-cause notice can then lead to either a partial- or full-licence cancellation or suspension. The law says nothing about a “warning letter”, and the use of this language in a Rajya Sabha makes one wonder exactly what the CDSCO did.

My conclusion? The CDSCO’s media blitz on risk-based inspections seems to be more PR than actual action. I’d like to see more evidence that this scheme will continue, and more transparency around its running.  

2. Healthy ministry notified the revised Schedule M (a move credited to Raghuvanshi)

In December 2023, the Indian health ministry notified a revision of the Schedule M, a list of good manufacturing practices (GMP) that all Indian plants are required to follow, mandatorily. The reason it was revised? India’s current Schedule M is not in line with global standards such as the World Health Organisation’s GMP, and is seen by many as woefully inadequate to ensure the quality and safety of medicines.

Again, this was good news. But does it really deserve hurrahs for its potential to transform the industry? I don’t think so.

First, recall that the new Schedule M was first published as a draft for comments by the health ministry in 2018. And as Kamat points out in his blog: the Schedule M that was notified in December 2023 was almost identical to the 2018 draft.

So, why did it take five years for the health ministry to make the new Schedule M mandatory?

The answer: resistance from the industry. For many years, lobbying groups such as the IDMA pushed back against the revision, arguing that the stringent standards would kill the small- and medium- industry. The IDMA had even suggested that the revised Schedule M first be implemented as an optional guideline, rather than a legally enforceable rule.

Given this history, the biggest factor behind the government pushing through the revised rules in 2024 seems to have been sheer compulsion. The government was desperate to redeem its image after the cough-syrup adulterations.

This doesn’t mean implementation will be smooth sailing, of course. The 2023 notification gives the small- and mid-scale industry upto one year to implement the new GMP, while larger companies with annual turnover above Rs 250 crore have six months.

But within days of the announcement, sections of the industry began asking for a postponement of these deadlines.  ET reported that a manufacturers’ association, called Laghu Udyog Bharti, which is affiliated with the RSS, said the deadlines were too short, and may lead to plant closures and drug shortages, given the high expenditure required.

It isn’t clear how the health ministry plants to address these claims. Is it going to help these plants upgrade infrastructure through incentives? Or will it merely postpone the deadline, after the elections are over, and the campaigning pressure is off? After all, it did delay notification of Schedule M for five years after the draft.  

Finally, Indian consumers also need to remember that regulators implemented the older Schedule M laxly. If they didn’t, we wouldn’t have seen the spate of quality incidents in the last couple of years. This goes back to the CDSCO and state regulators being unable to inspect plants often and thoroughly enough.

With the regulatory short-staffing remaining unaddressed, how exactly will regulators enforce the spanking new Schedule M? The answer: we don’t know. So, maybe we should hold off on the celebrations just yet. 

3. All cough syrup for exports to be quality tested in government labs (a move attributed to Raghuvanshi by News18)

This move was ethically problematic. 

In May, India’s Directorate General of Foreign Trade said no cough syrup could be exported from India, unless one of a network of government labs certified it for quality.

This was obviously aimed at preventing further incidents like the Gambian and Cameroon poisonings. But it completely ignores the fact that cough-syrup poisonings have repeatedly occurred within India, the latest being in Jammu and Himachal in 2020.

So, why did the CDSCO and Raghuvanshi decide to test only those syrups sold to foreign countries? Is the CDSCO less concerned about Indian lives because local adulterations don’t bring international shame onto us?

This theme of privileging India’s global reputation over local lives runs through CDSCO’s behaviour in the cough-syrup-testing program. After the initial announcement in May, in December, a number of articles claimed that the CDSCO had found over 54 cough-syrup manufacturers to have failed quality norms.

Interestingly, these erring manufacturers were allowed to reprocess the batches, instead of destroying them. Given that these companies likely sell the same formulations to Indians, how did the CDSCO ensure they didn’t make up for their export losses by dumping the drugs locally? If I am an unscrupulous manufacturer whose products are only tested when they are exported, that’s exactly how I would deal with rejects.

Of all of CDSCO’s and Raghuvanshi’s actions, this is the one I find the strangest. Yet, CNBC TV 18 chose to play it up, describing it as an example of the Indian government “keeping a strong vigil on the product and sector”.

4. CDSCO/states to launch an integrated information system

ET Prime’s congratulatory sketch of Raghuvanshi had another interesting detail. Raghuvanshi is said to be pushing for a regulatory ecosystem, which will link all “portals in the pharmaceutical supply chain” on a single platform. He says it will enable remote audits of manufacturing sites.  

This sounds extremely futuristic. For CDSCO and state regulators to conduct remote audits of a plant, the plant would have to digitise all its records. A physical audit involves studying the plants manufacturing processes, quizzing employees and looking at records such as quality test results, process validations etc. Very few Indian plants have such records digitised, and Raghuvanshi seems to be suggesting that they will get there.

These are excellent ambitions, but how achievable are they? Would an industry that didn’t accept a Schedule M upgrade for years agree to digitise all its records without a fuss? A practical timeline for this goal would be several years, even decades. And Raghuvanshi says that mere Expressions of Interest for this scheme have been floated so far.

If CDSCO is still looking for someone to build this grand digital infrastructure, should we even be talking about it? Especially given that several digital schemes have languished in the bin of regulator-inertia and industry-resistance before?

Sample the Extended Licensing System (XLN), for example, an online system of licencing, which also captures the results of quality testing for every state. According to this paper, state regulators started implementing this from 2007 onwards, with Gujarat being an early adopter.  The idea was for all Indian states to do so eventually.

Such a system held great promise. Take just the publication of substandard drug data on a timely basis, by every state. It can inform consumers about what batches to avoid. Also, state regulators can use this database to inform each other.

For instance, if the Gujarat regulator finds a substandard drug in its jurisdiction, and this drug is manufactured in Himachal Pradesh, the Gujarat regulator can alert the Himachal regulator about it, via XLN. This would enable to Himachal regulator to inspect the plant, and act against the firm. This is a very crucial bit of information that regulators are required to convey, but often don’t.

During my reporting on Digital Vision, for example, I found that the Maharashtra regulator had repeatedly found drugs from the Baddi-based company, Digital Vision, to be substandard.  In response, it intimated the Himachal regulator by post.  But the Himachal regulator claimed never to have received the letters, thus giving them an excuse to never act against Digital Vision. This meant that Digital Vision’s wrongdoings flew under the radar of the Himachal regulator for years, until its cough syrup killed children.

XLN could potentially have solved this problem if all states implemented it, and communicated substandard drug data through it. Yet, since 2007, only five states seem to be publishing their substandard drug data on XLN. Even CDSCO doesn’t publish its results on this database, choosing instead to publish it on its own website.

This is how easily digital ideas fizzle out. Perhaps, the promise of a futuristic end-to-end regulatory ecosystem should be taken with a grain of salt then?

Conclusion:  The four examples above explain why I think it’s very premature to sing praises of either Raghuvanshi, CDSCO or the health ministry. The problems plaguing Indian pharmaceutical quality run much deeper than the handful of bold moves from the DCGI can address. Those problems will take a decades-long plan, endorsed by multiple successive governments and health ministries, to solve.

The DCGI is limited by his tenure and his powers. His ambitions will forever be circumscribed by the political will of his masters. When the general elections are done, and the BJP is no longer in campaigning mode, the political will to redeem Indian pharma’s image may very well die.  The Gambian tragedy would have become a distant memory by then.  

At that point, Raghuvanshi may not be able to bend Mansukh Mandaviya’s ear as much as he can now. If the BJP wins again in 2024, RSS-linked lobbies like Laghu Gram Udhyog (see earlier discussion of Schedule M) will likely hold more sway over the party’s decisions than the DCGI does. That’s how things have happened historically. When the crisis ends, status quo is restored.

Perhaps Raghuvanshi will be able to push for a long-term plan, before his tenure ends in 2025.  Perhaps the BJP will remain committed to drug quality even when it doesn’t need to, anymore. Perhaps a different party will come to power, and will care about drug quality even more than the BJP does.

I would call these unprecedented events. I would also call them somewhat unlikely.

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The Ugly Truth About a Vaccine That Didn’t Work (Kannada translation)

This article was first published in the newspaper Mint under the title “The Ugly Truth About a Vaccine that Didn’t Work”. It was accompanied by three other pieces, titled NIV’s Troubling Role in the KFD Vaccine Saga, How the KFD Vaccine is Made and Tested, and The Mystery of the Missing CDSCO Scrutiny, respectively. This Kannada version was translated by science communicator Kollegala Sharma, whom you can follow here on Twitter.

If you wish to publish any article based on this piece, please credit Mint, and include a link to the original English article.

ನಿಷ್ಪ್ರಯೋಜಕ ಲಸಿಕೆ ಕುರಿತ ಕಹಿ ಸತ್ಯ 

ಪ್ರಿಯಾಂಕಾ ಪುಲ್ಲ 

ಬೆಂಗಳೂರು: ಅಕ್ಟೋಬರ್‌ ೧೦, ೨೦೨೨. ಕರ್ನಾಟಕ ಸರಕಾರದ ಆರೋಗ್ಯ ಹಾಗೂ ಕುಟುಂಬ ಕಲ್ಯಾಣ ಇಲಾಖೆಯು ತನ್ನೆಲ್ಲ ಜಿಲ್ಲಾ ಆರೋಗ್ಯಾಧಿಕಾರಿಗಳಿಗೆ ಒಂದು ವಿಚಿತ್ರವಾದೊಂದು ಸೂಚನೆಯನ್ನು ರವಾನಿಸಿತು. ಕನ್ನಡದಲ್ಲಿದ್ದ ಆ ಸೂಚನಾ ಪತ್ರದಲ್ಲಿ, ಕಾಡಿನ ವಾಸಿಗಳು ಹಾಗೂ ಕೃಷಿಕರನ್ನು ಬಾಧಿಸುವ ಕ್ಯಾಸನೂರು ಫಾರೆಸ್ಟ್‌ ಡಿಸೀಸ್‌ ಅಥವಾ ಮಂಗನಖಾಯಿಲೆ ಎಂದು ಖ್ಯಾತಿ ಪಡೆದ ಮಾರಕ ರೋಗದಿಂದ ರಕ್ಷಣೆಗೆಂದು ಬಳಸುವ ಲಸಿಕೆಗಳ ದಾಸ್ತಾನು ಖಾಲಿಯಾಗಿದೆ ಎಂದು ತಿಳಿಸಿತ್ತು. ದಾಸ್ತಾನು ಖಾಲಿಯಾದ ಕಾರಣದಿಂದ ರೋಗವು ಸಾಮಾನ್ಯವಾಗಿ ಸೋಂಕುವ ನವೆಂಬರಿನಿಂದ ಮೇ ಅವಧಿಯಲ್ಲಿ ಲಸಿಕೆಗಳು ದೊರೆಯುವುದಿಲ್ಲವೆಂದು ಆ ಪತ್ರ ತಿಳಿಸಿತ್ತು. ಆರೋಗ್ಯ ಇಲಾಖೆಯು ಈ ಉಣ್ಣೆಗಳಿಂದ ಹರಡುವ ಸೋಂಕನ್ನು ಜನತೆಯಲ್ಲಿ ಉಣ್ಣೆಕಡಿತವನ್ನು ತಪ್ಪಿಸಿಕೊಳ್ಳುವಂತಹ ಮಾರ್ಗೋಪಾಯಗಳ ಬಗ್ಗೆ ಜಾಗೃತಿ ಮೂಡಿಸಿ ಈ ಖಾಯಿಲೆಯನ್ನು ನಿಯಂತ್ರಿಸಬೇಕು ಎಂದು ಆರೋಗ್ಯಾಧಿಕಾರಿಗಳಿಗೆ ಸೂಚನೆ ನೀಡಿತ್ತು. 

ಹಲವು ಕಾರಣಗಳಿಂದಾಗಿ ಈ ಸೂಚನೆ ವಿಚಿತ್ರವೆನ್ನಿಸುತ್ತದೆ. ಮಂಗನ ಖಾಯಿಲೆಯನ್ನು ನಿಯಂತ್ರಿಸುವುದರಲ್ಲಿ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯೇ ಪ್ರಮುಖ ಹಾಗೂ ಮುಂಚೂಣಿ ಆಯುಧವೆಂಬುದು ಸಾಮಾನ್ಯ ನಂಬಿಕೆ. ಏಕೆಂದರೆ ಈ ರೋಗಕ್ಕೆ ನಿರ್ದಿಷ್ಟ ಚಿಕಿತ್ಸೆಯೇ ಇಲ್ಲ. ಅಲ್ಲದೆ ಸೋಂಕಿನ ಅಪಾಯಗಳು ಹೆಚ್ಚಿರುವಂತಹ ಅರಣ್ಯ ಇಲಾಖೆಯ ಸಿಬ್ಬಂದಿಗಳಿಗೆ ಉಣ್ಣೆ ಗಳ ಕಡಿತದಿಂದ ದೂರವಿರುವುದು ಸುಲಭವಲ್ಲ. ಜೊತೆಗೆ ಈ ಲಸಿಕೆಯನ್ನು ಕಳೆದ ಇಪ್ಪತ್ತಮೂರು ವರ್ಷಗಳಿಂದಲೂ ರಾಜ್ಯದಲ್ಲ ಬಳಸಿತ್ತಲ್ಲ? ಇದೀಗ ಇದ್ದಕ್ಕಿದ್ದಂತೆ ಈ ಲಸಿಕೆಯ ಬಳಕೆಯನ್ನು ನಿಲ್ಲಿಸುವಂತೆ ಆರೋಗ್ಯ ಇಲಾಖೆ ನಿಶ್ಚಯಿಸಲು ಕಾರಣವಾದರೂ ಏನಿರಬಹುದು?

ಸೂಚನಾಪತ್ರವು ತಿಳಿಸದೇ ಇದ್ದ ಒಂದು ಅಂಶವೆಂದರೆ ಸರಕಾರದ ಈ ತೀರ್ಮಾನ ತಕ್ಷಣದ್ದಾಗಿರಲಿಲ್ಲ ಎನ್ನುವುದು. ಬದಲಿಗೆ, ಈ ಲಸಿಕೆಯ ಕುರಿತಂತೆ ನಿಯಮಪಾಲನೆ ಹಾಗೂ ಗುಣಮಟ್ಟಗಳೆರಡಲ್ಲಿಯೂ ಕಳೆದ ಎರಡು ದಶಕಗಳಿಂದಲೂ ಸಮಸ್ಯೆಗಳು ಕಂಡು ಬಂದಿದ್ದುವು. ಇವುಗಳಲ್ಲಿ ಪ್ರಮುಖವಾದುದೆಂದರೆ ಕೇಂದ್ರೀಯ ಔಷಧ ಮಾನಕ ನಿಯಂತ್ರಣ ಸಂಸ್ಥೆ (Central Drugs Standard Control Organisation-CDSCO), ಬೆಂಗಳೂರಿನಲ್ಲಿರುವ ಲಸಿಕೆಯ ತಯಾರಕ ಇನ್ಸ್‌ಟಿಟ್ಯೂಟ್‌ ಆಫ್‌ ಅನಿಮಲ್‌ ಹೆಲ್ತ್‌ ಅಂಡ್‌ ವೆಟರಿನರಿ ಬಯಾಲಾಜಿಕಲ್ಸ್‌ ಎನ್ನುವ ಸಂಸ್ಥೆಗೆ ಕನಿಷ್ಠವೆಂದರೂ 2002 ರಿಂದಲೂ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆ ತಯಾರಿಸಲು ಪರವಾನಿಗಿಯನ್ನು ನೀಡಿರಲಿಲ್ಲ. ಇನ್ನೊಂದು ರೀತಿ ಹೇಳುವುದಾದರೆ, ಕಳೆದ ಇಪ್ಪತ್ತೊಂದು ವರ್ಷಗಳಿಂದ ದೇಶದಲ್ಲಿ ಈ ಲಸಿಕೆಯ ಮಾರಾಟ ಮತ್ತು ಉಪಯೋಗ ನಿಯಮಬಾಹಿರವಾಗಿತ್ತು.  ಅಕ್ಟೋಬರ್‌ 2022ರಲ್ಲಿ ಇಲಾಖೆಯು ಸುತ್ತೋಲೆ ಕಳಿಸುವ ಮುನ್ನವೇ ಮಿಂಟ್‌ ಪತ್ರಿಕೆ ಈ ಸಂಗತಿಯನ್ನು ಪತ್ತೆ ಮಾಡಿತ್ತು.

ಸಿ.ಡಿ.ಎಸ್‌.ಸಿ.ಓ ನಿಯಂತ್ರಣವಿಲ್ಲದ್ದರಿಂದ, ಈ ಲಸಿಕೆಯ ಗುಣಮಟ್ಟ ಕಳೆದ ಎರಡು ದಶಕಗಳಲ್ಲಿ ಗಣನೀಯವಾಗಿ ಕುಗ್ಗಿತ್ತು. ವಿಶೇಷವಾಗಿ, ಮತ್ತೆ ಮತ್ತೆ ನಡೆಸಿದ ʼಪೊಟೆನ್ಸಿʼ (ಸಾಮರ್ಥ್ಯ) ಪರೀಕ್ಷೆಯಲ್ಲಿ ಈ ಲಸಿಕೆ ಪಾಸಾಗಿರಲಿಲ್ಲ. ಪ್ರಾಣಿಗಳ ಮೇಲೆ ಪ್ರಯೋಗಿಸಿ ನಡೆಸುವ ಪೊಟೆನ್ಸಿ ಪರೀಕ್ಷೆ, ಲಸಿಕೆಯು ಕೆಏಫ್‌ಡಿ ಸೋಂಕಿನ ವಿರುದ್ಧ ಮನುಷ್ಯರನ್ನು ಎಷ್ಟರ ಮಟ್ಟಿಗೆ ರಕ್ಷಿಸಬಲ್ಲುದು ಎನ್ನುವುದರ ಸೂಚಿ. ಅಂದರೆ ಲಸಿಕೆಯ ಪೊಟೆನ್ಸಿಗೂ, ಅದರ ಕ್ಷಮತೆ ಅಥವಾ ಸಾಮರ್ಥ್ಯಕ್ಕೂ ಸಂಬಂಧವಿದೆ ಎಂದಾಯಿತು. ಲಸಿಕೆಯು ಪೊಟೆನ್ಸಿ ಪರೀಕ್ಷೆಯನ್ನು ಪಾಸಾಗಿಲ್ಲವೆಂದರೆ ಅದು ಕೆಏಫ್‌ಡಿ ಸೋಂಕಿನಿಂದ ಜನರನ್ನು ರಕ್ಷಿಸಲಾರದು ಎಂದರ್ಥವಷ್ಟೆ

ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ತಯಾರಕ ಐಎಎಚ್‌ವಿಬಿ (ಇನ್ಸ್‌ಟಿಟ್ಯೂಟ್‌ ಆಫ್‌ ಅನಿಮಲ್‌ ಹೆಲ್ತ್‌ ಅಂಡ್‌ ವೆಟರಿನರಿ ಬಯಾಲಾಜಿಕಲ್ಸ್‌), ಹಾಗೂ ಶಿವಮೊಗ್ಗೆಯಲ್ಲಿದ್ದ ಸರ್ಕಾರಿ ವೈರಸ್‌ ಡಯಾಗ್ನೋಸ್ಟಿಕ್‌ ಲ್ಯಾಬೊರೇಟರಿ (ವಿ.ಡಿ.ಎಲ್‌)ಗಳು ಪೊಟೆನ್ಸಿ ಪರೀಕ್ಷೆಯಲ್ಲಿ ಅನುತ್ತೀರ್ಣವಾಗಿದ್ದರೂ ಸಾರ್ವಜನಿಕರ ಬಳಕೆಗೆಂದು ಈ ಲಸಿಕೆಯನ್ನು ಬಿಡುಗಡೆ ಮಾಡಿದ ಕನಿಷ್ಠ ಎರಡು ಸಂದರ್ಭಗಳನ್ನು ಮಿಂಟ್‌ ಪತ್ತೆ ಮಾಡಿದೆ. ಈ ಕೆಟ್ಟ ತೀರ್ಮಾನಗಳನ್ನು ಕರ್ನಾಟಕದ ಆರೋಗ್ಯ ಇಲಾಖೆ ಒಪ್ಪಿಕೊಂಡಿತ್ತು.

ಐ.ಎ.ಎಚ್‌.ವಿ.ಬಿ, ವಿ.ಡಿ.ಎಲ್‌, ಹಾಗೂ ಆರೋಗ್ಯ ಇಲಾಖೆಗಳು ಪ್ರತ್ಯೇಕವಾಗಿ ಈ ತೀರ್ಮಾನವನ್ನು ತೆಗೆದುಕೊಂಡಿಲ್ಲವೆಂದು ಮಿಂಟ್‌ ನಡೆಸಿದ ಶೋಧ ತಿಳಿಸಿದೆ. ಇವುಗಳ ತೀರ್ಮಾನಗಳಿಗೆ ಸಾರ್ವಜನಿಕ ಅರೋಗ್ಯ ಸಂಸ್ಥೆಗಳಲ್ಲಿ ರಾಷ್ಟ್ರದಲ್ಲಿಯೇ ಅತ್ಯುನ್ನತ ಸ್ಥಾನದಲ್ಲಿರುವ ರಾಷ್ಟ್ರೀಯ ವೈರಾಲಜಿ ಸಂಸ್ಥೆ (ನ್ಯಾಶನಲ್‌ ಇನ್ಸ್‌ಟಿಟ್ಯೂಟ್‌ ಆಫ್‌ ವೈರಾಲಜಿ, ಎನ್‌.ಐ.ವಿ)ಯು ಲಸಿಕೆಯನ್ನು ತಯಾರಿಸದಂತೆ ಐ.ಎ.ಎಚ್‌.ವಿ.ಬಿ.ಗೆ ನಿರ್ದೇಶ ನೀಡು ಬದಲಿಗೆ ಪೊಟೆನ್ಸಿ ಕುಗ್ಗುವುದನ್ನು ತಡೆಯಲು ಕೆಲವು ತೋರಿಕೆಯ ಕ್ರಮಗಳನ್ನು ಕೈಗೊಳ್ಳಲು ಸಲಹೆ ನೀಡಿತ್ತು. ಭಾರತದ ಅತ್ಯುನ್ನತ ವೈದ್ಯಕೀಯ ಸಂಶೋಧನಾ ಸಂಸ್ಥೆ ಇಂಡಿಯನ್‌ ಕೌನ್ಷಿಲ್‌ ಆಫ್‌ ಮೆಡಿಕಲ್‌ ರೀಸರ್ಚಿನ ಅಂಗವಾಗಿರುವ ಎನ್‌.ಐ.ವಿ ಹೀಗೆ ಪರಿಣಾಮಕಾರಿಯಲ್ಲದ ಲಸಿಕೆಗಳ ತಯಾರಿಕೆಗೆ ಹಾಗೂ ಅದರ ಸಾರ್ವಜನಿಕ ಬಳಕೆಗೆ ನೆರವಾಗಿತ್ತು. 

ಹಲವು ಸ್ತರಗಳಲ್ಲಿದ್ದ ಈ ಎಲ್ಲ ಸಂಸ್ಥೆಗಳ ವೈಫಲ್ಯಕ್ಕೆ ಜನರೇ ಬೆಲೆಯನ್ನು ತೆರಬೇಕಾಯಿತು. ಬಹಳ ಕಾಲದಿಂದ ಐ.ಎ.ಎಚ್‌.ವಿ.ಬಿಯಿಂದ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಗಳನ್ನು ಐದು ರಾಜ್ಯಗಳು, ಕರ್ನಾಟಕ, ಗೋವ, ಮಹಾರಾಷ್ಟ್ರ, ತಮಿಳುನಾಡು ಹಾಗೂ ಕೇರಳ ರಾಜ್ಯಗಳು, ಖರೀದಿಸುತ್ತವೆ. ಈ ಎಲ್ಲ ರಾಜ್ಯಗಳೂ ಅಷ್ಟೇನೂ ಪರಿಣಾಮಕಾರಿಯಲ್ಲದ, ಹಾಗೂ ಗುಣಮಟ್ಟ ಮತ್ತು ಸುರಕ್ಷತೆಯೇ ಸಂದೇಹಾಸ್ಪದವಾದ ಲಸಿಕೆಗಳನ್ನು ಕೊಳ್ಳಲು ಹಣ ತೆತ್ತಿದ್ದುವು. 

ಚೆನ್ನೈನಲ್ಲಿರುವ ನ್ಯಾಶನಲ್‌ ಇನ್ಸ್‌ಟಿಟ್ಯೂಟ್‌ ಆಫ್‌ ಎಪಿಡೆಮಿಯಾಲಜಿ ನಡೆಸಿದ ಅಧ್ಯಯನಗಳು ಈ ಲಸಿಕೆಗಳ ಪರಿಣಾಮಗಳು 2000ನೇ ಇಸವಿಯ ಮಧ್ಯಭಾಗದಿಂದ ಗುರುತರವಾಗಿ ಕ್ಷೀಣಿಸಿದ್ದುವು ಎಂದು ತಿಳಿಸಿವೆ. ಭಾರತೀಯ ವೈದ್ಯಕೀಯ ಸಂಶೋಧನಾ ಮಂಡಳಿಯ ಸಂಸ್ಥೆ ಎನ್‌.ಐ.ವಿಯ ಸೋದರ ಸಂಸ್ಥೆಯಾದ ನ್ಯಾಶನಲ್‌ ಇನ್ಸ್‌ಟಿಟ್ಯೂಟ್‌ ಆಫ್‌ ಎಪಿಡೆಮಿಯಾಲಜಿಯು ಕೆಎಫ್‌ಡಿ ಕುರಿತ 2005-2010ರವರೆಗಿನ ಮಾಹಿತಿಯನ್ನು ಬಳಸಿಕೊಂಡು ಈ ಅವಧಿಯಲ್ಲಿ ಒಂದು ಡೋಸು ಲಸಿಕೆಯ ಪರಿಣಾಮ ಶೂನ್ಯವೆಂದು ಪತ್ತ ಮಾಡಿತ್ತು. 1994ರಲ್ಲಿ ನಡೆಸಿದ್ದ ಅಧ್ಯಯನದಲ್ಲಿ ಇದು 79.3% ಇತ್ತು. ಎರಡು ಡೋಸುಗಳ ಪರಿಣಾಮಗಳು, 1994ರಲ್ಲಿದ್ದ 94.5%ಗೆ ಹೋಲಿಸಿದರೆ ಈಗ ಕೇವಲ 62% ಆಗಿತ್ತು. 

ಅಂದರೆ ಈ ಲಸಿಕೆಯ ಒಂದು ಡೋಸನ್ನಷ್ಟೆ ಪಡೆದಿದ್ದ ಬಹುತೇಕ ಜನತೆಗೆ ಮಾರಕವಾದ ಕೆಎಫ್‌ಡಿ ಸೋಂಕಿನಿಂದ ರಕ್ಷಣೆ ಇರಲೇ ಇಲ್ಲ. ಈ ರಾಜ್ಯಗಳ ಪಶ್ಚಿಮ ಘಟ್ಟಗಳ ಪ್ರಾಂತ್ಯದಲ್ಲಿ ಪ್ರತಿ ವರ್ಷವೂ ಸುಮಾರು 500 ಮಂದಿಯನ್ನು ಖಾಯಿಲೆಗೀಡು ಮಾಡುವ ಈ ಸೋಂಕು ಸಾಮಾನ್ಯವಾಗಿ ಜ್ವರ, ಛಳಿಜ್ವರವನ್ನಷ್ಟೆ ಉಂಟು ಮಾಡುತ್ತದೆ. ಸೋಂಕಿದ 5-10% ರೋಗಿಗಳಲ್ಲಿ ವೈರಸ್ಸು ತೀವ್ರತೆರನ ಖಾಯಿಲೆಯುಂಟು ಮಾಡಿ ಸಾವನ್ನು ತರಬಹುದು. ತೀವ್ರತೆರನ ಖಾಯಿಲೆಯ ಸಂದರ್ಭದಲ್ಲಿ ವೈರಸ್ಸು ಹಲವು ಅಂಗಗಳನ್ನು ಬಾಧಿಸಿ ಕಣ್ಣು, ಮೂಗು ಹಾಗೂ ಕರುಳುಗಳಲ್ಲಿ ರಕ್ತ ಸೋರಿಕೆಯಂತಹ ಲಕ್ಷಣಗಳನ್ನು ಉಂಟು ಮಾಡುತ್ತದೆ. ಐದರಿಂದ ಹತ್ತು ಶತಾಂಶ ಮರಣವೆನ್ನುವುದು ಕಡಿಮೆ ಪ್ರಮಾಣವೇನಲ್ಲ. ಇದಕ್ಕೆ ಹೋಲಿಸಿದರೆ, ಒಂದು ಅಂದಾಜಿನ ಪ್ರಕಾರ ಡೆಂಗ್ಯೂ ಸೋಂಕು ಖಚಿತವಾದವರಲ್ಲಿ ಸುಮಾರು 2.6% ಮಂದಿಯನ್ನಷ್ಟೆ ಕೊಲ್ಲುತ್ತದೆ. 

ಲಸಿಕೆಯ ಕ್ಷಮತೆ ಕುಸಿಯುತ್ತಿರುವುದು ಕೆಎಫ್‌ಡಿ ಬಾಧಿತ ಪ್ರದೇಶಗಳಲ್ಲಿ ಕಾರ್ಯನಿರತರಾಗಿದ್ದ ಆರೋಗ್ಯಸೇವೆಯ ಸಿಬ್ಬಂದಿಗಳ ಗಮನಕ್ಕೂ ಬಂದಿತ್ತು. ಹಲವರು ಲಸಿಕೆಯ ಬಗ್ಗೆ ವಿಶ್ವಾಸ ಕಳೆದುಕೊಂಡಿದ್ದರು. “ಅದು ಕೆಲಸ ಮಾಡುವಂತೆ ಕಾಣಲ್ಲ.” ಎಂದು ಶಿವಮೊಗ್ಗದ ಕನ್ನಂಗಿ ಗ್ರಾಮದಲ್ಲಿ ಸಮುದಾಯ ಆರೋಗ್ಯಾಧಿಕಾರಿಯಾಗಿರುವ ಕೃಷ್ಣ ಎಂಬಾತ ಜುಲೈ 2022ರಲ್ಲಿ ಮಿಂಟ್‌ಗೆ ತಿಳಿಸಿದ್ದರು. 

ಭಾರತ ರಫ್ತು ಮಾಡಿದ ಕಲಬೆರಕೆ ಕೆಮ್ಮಿನ ಔಷಧವನ್ನು ಕುಡಿದು ಗ್ಯಾಂಬಿಯಾ ದೇಶದ 69 ಮಕ್ಕಳು ಮರಣಿಸಿದ್ದರ ಹಿನ್ನೆಲೆಯಲ್ಲಿ ಈ ಇಡೀ ಘಟನೆ ಭಾರತದ ರಾಷ್ಟ್ರೀಯ ನಿಯಂತ್ರಣ ಸಂಸ್ಥೆಯಾಗಿ ಸಿ.ಡಿ.ಎಸ್‌.ಸಿ.ಓದ ಕಾರ್ಯಕ್ಷಮತೆಯನ್ನು ಪ್ರಶ್ನಿಸುತ್ತದೆ.

2020ನೇ ಇಸವಿಯಿಂದಲೂ ಕರ್ನಾಟಕದಲ್ಲಿ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯನ್ನು ಅದರ ಪರವಾನಿಗಿ ಇಲ್ಲದೆಯೇ ಬಳಸಲಾಗುತ್ತಿದೆ ಎಂದು ಸಿ.ಡಿ.ಎಸ್‌.ಸಿ.ಓ ಗೆ ಮತ್ತೆ ಮತ್ತೆ ತಿಳಿಸಿದ್ದರೂ, ಈ ರಾಷ್ಟ್ರೀಯ ನಿಯಂತ್ರಣ ಸಂಸ್ಥೆ ಪರಿಹಾರಕ್ಕಾಗಿ ಯಾವ ಕ್ರಮವನ್ನೂ ಕೈಗೊಳ್ಳಲಿಲ್ಲವೆಂದು ಮಿಂಟ್‌ಗೆ ತಿಳಿದುಬಂದಿದೆ. 

ಆರಂಭ 

ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ಕಥೆಯಲ್ಲಿ ಎನ್‌ಐವಿ ಸಂಸ್ಥೆಯ ಪಾತ್ರ ಪ್ರಶ್ನಾರ್ಹವಾಗಿದ್ದರೂ, ಚಾರಿತ್ರಿಕವಾಗಿ ಈ ಖಾಯಿಲೆಯ ಅಧ್ಯಯನ ಹಾಗೂ ಅದಕ್ಕಾಗಿ ಲಸಿಕೆಯನ್ನು ಅಭಿವೃದ್ಧಿ ಪಡಿಸುವಲ್ಲಿ ಅದರ ಕೊಡುಗೆ ಆದ್ಯಪ್ರವರ್ತಕವೆಂದೆನಿದೆ ಎನ್ನುವುದು ಸತ್ಯ. 1957ನೇ ಇಸವಿಯಲ್ಲಿ ಮಲೆನಾಡಿನಲ್ಲಿ ಭತ್ತದ ಗದ್ದೆಗಳ ಜೊತೆಗೆ ಇದ್ದ ಕ್ಯಾಸನೂರು ಕಾಡಿನಿಂದ ಖಾಯಿಲೆಗೆ ಕಾರಣವಾದ ವೈರಸ್ಸನ್ನು ಮೊತ್ತ ಮೊದಲಿಗೆ ಪ್ರತ್ಯೇಕಿಸಿದ್ದು ಎನ್‌ಐವಿಯ ವಿಜ್ಞಾನಿಗಳು. 

ಸ್ಳೀಯರಲ್ಲಿ ಆಗ ಕಾಣಿಸಿಕೊಂಡಿದ್ದ ಮಿದುಳಿನಲ್ಲಿ ರಕ್ತಸ್ರಾವವುಂಟು ಮಾಡುತ್ತಿದ್ದ ನಿಗೂಢ ಖಾಯಿಲೆಯ ಬಗ್ಗೆ ಅವರು ಸಂಶೋಧನೆ ನಡೆಸಿದ್ದರು. ಈ ಖಾಯಿಲೆ ಕಾಣಿಸಿಕೊಂಡ ಸಂದರ್ಭದಲ್ಲಿಯೇ ಅಲ್ಲಿದ್ದ ಮಂಗಗಳು ಸಾಯುತ್ತಿದ್ದುದು ಕಂಡು ಬಂದಿತು. ಇದು ಹಳದಿ ಜ್ವರ ಇರಬಹುದೇ ಎನ್ನುವ ಗುಮಾನಿ ಎದ್ದಿತು.  ಮನುಷ್ಯರು ಹಾಗೂ ಮಂಗಗಳಲ್ಲಿ ಮಿದುಳಿನ ರಕ್ತಸ್ರಾವವನ್ನುಂಟು ಮಾಡುವ ಹಳದಿ ಜ್ವರ ಆಗ ಕೇವಲ ದಕ್ಷಿಣ ಅಮೆರಿಕಾ ಹಾಗೂ ಆಫ್ರಿಕಾಗಳಿಗೆ ಮಾತ್ರ ಸೀಮಿತವಾಗಿತ್ತು. ಎನ್‌ಐವಿ ಸಂಸ್ಥೆಯ ವಿಜ್ಞಾನಿಗಳು ಮಲೆನಾಡಿನ ಸಿಂಗಳೀಕಗಳಿಂದ ವೈರಸ್ಸನ್ನು ಪ್ರತ್ಯೇಕಿಸಿದ ಅವರಿಗೆ ಇದು ಹಳದಿ ಜ್ವರದಿಂದ ಭಿನ್ನವಾದೊಂದು ರೋಗಾಣುವೆಂಬುದು ಖಾತ್ರಿಯಾಯಿತು. ಕ್ಯಾಸನೂರು ಕಾಡಿನಲ್ಲಿ ದೊರೆತ ಈ ವೈರಸ್ಸನ್ನು ಕ್ಯಾಸನೂರು ಕಾಡಿನ ಖಾಯಿಲೆ ಎಂದೇ ಹೆಸರಿಸಿದರು. 

ಕಾಡಿನಿಂದ ಈ ವೈರಸ್ಸು ಹೇಗೆ, ಎಲ್ಲಿಂದ ಸಾಗಿ ಬರುತ್ತಿದೆ ಎನ್ನುವ ಬಗ್ಗೆ ಖಚಿತವಾದೊಂದು ತರ್ಕವನ್ನು ತಿಳಿಸಿದವರೂ ಎನ್‌ಐವಿಯ ವಿಜ್ಞಾನಿಗಳೇ. ಇವರ ಸಂಶೋಧನೆಗಳು ಈ ವೈರಸ್ಸು ಇಲಿ, ಹೆಗ್ಗಣಗಳಂತಹ ದಂಶಕಗಳಲ್ಲಿ ಬದುಕಿರುತ್ತವೆ ಎಂದು ಸೂಚಿಸಿತ್ತು. ಅಲ್ಲದೆ ಸೋಂಕು ಹರಡುವುದರಲ್ಲಿ ಮಂಗಗಳು ಪ್ರಮುಖ ಪಾತ್ರ ವಹಿಸುತ್ತವೆನ್ನುವುದನ್ನು ಕೂಡ ಪತ್ತೆ ಮಾಡಿದರು. ಉಣ್ಣೆ ಕೀಟಗಳು ಮಂಗಗಳಿಗೆ ಸೋಂಕನ್ನು ಹರಡಿದಾಗ, ಮಂಗಗಳ ದೇಹದಲ್ಲಿ ವೈರಸ್ಸಿನ ಸಂಖ್ಯೆ ಹೆಚ್ಚುತ್ತಿತ್ತು. ಮಂಗಗಳು ವೈರಸ್ಸಿನ ಸೋಂಕುಮೂಲಗಳಾಗುತ್ತಿದ್ದುವು.  ಇಂತಹ ರೋಗಿಷ್ಟ ಮಂಗಗಳ ಸಂಪರ್ಕಕ್ಕೆ ಕಾಡಿನ ಬಳಿಯ ನಿವಾಸಿಗಳು ಬಂದಾಗ, ಉಣ್ಣೆ ಗಳ ಕಡಿತದ ಮೂಲಕ ಸೋಂಕು ಅವರಿಗೂ ಹರಡುವ ಸಾಧ್ಯತೆಗಳು ಹೆಚ್ಚುತ್ತಿದ್ದುವು. ಇದುವೇ ಕ್ಯಾಸನೂರು ಫಾರೆಸ್ಟ್‌ ಖಾಯಿಲೆಯನ್ನು ಮಂಗನ ಖಾಯಿಲೆ ಎಂದು ಕರೆಯುವುದಕ್ಕೂ ಕಾರಣ.

1960ರ ದಶಕದಲ್ಲಿ ಎನ್‌.ಐ.ವಿ ಇನ್ನೊಂದು ಮುನ್ನಡೆ ಸಾಧಿಸಿತ್ತು. ಸಿ.ಎನ್‌ ದಂಡವತೆಯವರ ನೇತೃತ್ವದಲ್ಲಿ ಅಲ್ಲಿನ ವೈರಸ್‌ ತಜ್ಞರು ಫಾರ್ಮಾಲಿನಿನಿಂದ ನಿಶ್ಶಕ್ತಗೊಳಿಸಿವ ವೈರಸ್ಸಿನ ಲಸಿಕೆಗಳನ್ನು ಅಭಿವೃದ್ಧಿಪಡಿಸಿದರು. ಎನ್‌.ಐ.ವಿ.ಯ ಸಿಬ್ಬಂದಿಗಳ ಮೇಲೆ ನಡೆದ ಆರಂಭದ ಪ್ರಯೋಗಗಳು ಹಾಗೂ ತದನಂತರದಲ್ಲಿ ಶಿವಮೊಗ್ಗೆಯ ಜನತೆಯ ಮೇಲೆ ನಡೆಸಿದ ಅಧ್ಯಯನಗಳು ಈ ಲಸಿಕೆಯು ದೇಹದಲ್ಲಿ ಪ್ರತಿಕಾಯಗಳು ಹುಟ್ಟುವಂತೆ ಮಾಡುವುದಷ್ಟೆ ಅಲ್ಲ, ಕೆಎಫ್‌ಡಿ ಖಾಯಿಲೆಯಿಂದ ರಕ್ಷಿಸುತ್ತದೆ ಎಂದೂ ತಿಳಿಸಿದುವು. 

ದಂಡವತೆಯವರ ಈ ಅಧ್ಯಯನಗಳು ಇದಕ್ಕಿಂತ ಸಕಾಲಿಕವಾಗಿರಲಿಕ್ಕಿಲ್ಲ. ಆರಂಭದಲ್ಲಿ ಶಿವಮೊಗ್ಗೆಯ ಪ್ರದೇಶಕ್ಕಷ್ಟೆ ಸೀಮಿತವಾಗಿದ್ದ ಸೋಂಕಿನ ಜಾಡು ಕ್ರಮೇಣ ವಿಸ್ತಾರವಾಗುತ್ತಿತ್ತು. ಕರ್ನಾಟಕದಲ್ಲಿ ಬೇರೆ ಜಿಲ್ಲೆಗಳಲ್ಲಿ ಕಾಣಿಸಿಕೊಂಡ ನಂತರ ನಾಲ್ಕು ದಶಕಗಳ ಸಮಯದಲ್ಲಿ ಈ ಖಾಯಿಲೆ ಮಹಾರಾಷ್ಟ್ರ, ಗೋವ, ಕೇರಳ ಮತ್ತು ತಮಿಳುನಾಡಿನ ಪ್ರದೇಶಗಳಿಗೂ ವ್ಯಾಪಿಸಿತು. 

ಈ ಎಲ್ಲ ಕಡೆಯಲ್ಲಿಯೂ ಸೋಂಕು ಅರಣ್ಯ ಅಥವಾ ಕೃಷಿ ಸಿಬ್ಬಂದಿಯನ್ನು ತಾಕುತ್ತದೆನ್ನುವುದು ವಿಶೇಷ. ಉಲ್ಬಣ ಸ್ಥಿತಿಯಲ್ಲಿ ಇದು ವ್ಯಕ್ತಿಯನ್ನು ಕೊಲ್ಲಬಹುದು ಇಲ್ಲವೇ ಹಲವಾರು ತಿಂಗಳುಗಳ ಕಾಲ ಹಾಸಿಗೆ ಹಿಡಿಸಿ, ಆದಾಯದಲ್ಲಿ ನಷ್ಟವನ್ನುಂಟು ಮಾಡುತ್ತಿತ್ತು. 

ದಾವಣಗೆರೆ ಜಿಲ್ಲೆಯ ಸಿಎಸ್‌ ರಾಘವೇಂದ್ರ ಇಂತಹ ಒಬ್ಬ ರೋಗಿ. ನಲವತ್ತೆರಡು ವರ್ಷ ವಯಸ್ಸಿನ ರಾಘವೇಂದ್ರ 2022ನೇ ಇಸವಿಯಲ್ಲಿ ಜ್ವರದಿಂದ ನರಳಿದ್ದರು. ಜ್ವರ ಗುಣವಾಗಲೇ ಇಲ್ಲ. ಕೆಎಫ್‌ಡಿ ಸೋಂಕು ಇದುವರೆಗೂ ಕಾಣದೇ ಇದ್ದಂತಹ ದಾವಣಗೆರೆಯಲ್ಲಿ ವಾಸವಿದ್ದರಿಂದ ಉಣ್ಣೆ ತರುವ ಸೋಂಕು ಈತನಿಗೆ ತಾಕಿದೆ ಎಂದು ಯಾವ ವೈದ್ಯರೂ ಊಹಿಸಲಿಲ್ಲ. ಹತ್ತು ದಿನಗಳಾದರೂ ಜ್ವರ ಕಡಿಮೆಯಾಗದಿದ್ದಾಗ, ಅವರ ಕುಟುಂಬದವರು ರಾಘವೇಂದ್ರರನ್ನು ಅನತಿ ದೂರದಲ್ಲಿದ್ದ ಶಿವಮೊಗ್ಗ ಜಿಲ್ಲೆಯ ಆಸ್ಪತ್ರೆಯೊಂದಕ್ಕೆ ಕರೆದೊಯ್ದರು. ಆಸ್ಪತ್ರೆ ತಲುಪುವಷ್ಟರಲ್ಲಿ ಸೋಂಕು ಈತನ ಮಿದುಳನ್ನು ಕವಿದು ಈತ ಕೋಮ ಸ್ಥಿತಿಗೆ ಜಾರಿದರು.

ಹೀಗಾದಾಗ ಶಿವಮೊಗ್ಗದ ವೈದ್ಯರಿಗೆ ಇದು ಕೆಎಫ್‌ಡಿ ಇರಬಹುದೇ ಎನ್ನುವ ಅನುಮಾನ ಹುಟ್ಟಿ, ರಕ್ತದ ಮಾದರಿಗಳನ್ನು ಪರೀಕ್ಷೆಗೆಂದು ಕಳಿಸಿದರು. ಫಲಿತಾಂಶ ಹೌದು ಎಂದಿತು. ದಾವಣಗೆರೆಯಿಂದ ಕೆಎಫ್‌ಡಿ ಸಾಮಾನ್ಯವಾಗಿರುವ ಶಿವಮೊಗ್ಗೆಯ ಹಳ್ಳಿಯೊಂದಕ್ಕೆ ಒಂದು ದಿನದ ಭೇಟಿ ನೀಡಿದ್ದ ಸಂದರ್ಭದಲ್ಲಿ ತನಗೆ ಸೋಂಕು ತಗುಲಿರಬೇಕು ಎನ್ನುತ್ತಾರೆ ರಾಘವೇಂದ್ರ. 

ಆಸ್ಪತ್ರೆಯಲ್ಲಿ ಒಟ್ಟು ಹನ್ನೆರಡು ದಿನಗಳನ್ನು ರಾಘವೇಂದ್ರ ಕಳೆಯಬೇಕಾಯಿತು. ಉಸಿರಾಟಕ್ಕಾಗಿ ಕೆಲವು ದಿನಗಳು ವೆಂಟಿಲೇಟರನ್ನೂ ಬಳಸಬೇಕಾಯಿತು. ಆಸ್ಪತ್ರೆಗೆಂದು ಆತನ ಕುಟುಂಬ ಹೆಚ್ಚೂ ಕಡಿಮೆ ಮೂರು ಲಕ್ಷ ರೂಪಾಯಿಗಳನ್ನು ವೆಚ್ಚ ಮಾಡಿತ್ತು. ಕೋಮ ಸ್ಥಿತಿಯಿಂದ ಮರಳಿದ ರಾಘವೇಂದ್ರ ಸಾಕಷ್ಟು ತೂಕ ಕಳೆದುಕೊಂಡಿದ್ದರು. ನರಗಳ ತೊಂದರೆಯೂ ಕಾಡಿತ್ತು. “ಆ ನರಕವನ್ನು ವಿವರಿಸಲು ಸಾಧ್ಯವಿಲ್ಲ. ನಡೆಯುವುದೂ ಕಷ್ಟ ಎನಿಸುತ್ತಿತ್ತು.” ಎನ್ನುತ್ತಾರೆ ರಾಘವೇಂದ್ರ. ವರ್ಷಗಳ ನಂತರ ಈಗ ತಾನು ಪೂರ್ಣವಾಗಿ ಗುಣವಾಗಿದ್ದರೂ, ಮರೆವಿನಂತಹ ತೊಂದರೆಗಳು ಇನ್ನೂ ಕಾಡುತ್ತಿವೆ ಎನ್ನುತ್ತಾರೆ.

ಕರ್ನಾಟಕದ ಅರಣ್ಯ ಪ್ರದೇಶಗಳ ನಿವಾಸಿಗಳಿಗೆ ಇದು ಉಂಟು ಮಾಡುವ ತೊಂದರೆಯಿಂದಾಗಿ ಕೆಎಫ್‌ಡಿ ನಿಯಂತ್ರಣ ರಾಜಕೀಯ ಮಹತ್ವ ಪಡೆದಿದೆ. ಉಣ್ಣೆ ಗಳ ಕಡಿತದಿಂದ ತಪ್ಪಿಸಿಕೊಳ್ಳುವುದು ಅರಣ್ಯವಾಸಿಗಳಿಗೆ ಸಾಧ್ಯವಿಲ್ಲವಾದ್ದರಿಂದ, ಲಸಿಕೆಗಳಿಗೆ ಬೇಡಿಕೆಯೂ ಹೆಚ್ಚು. 2019ನೇ ಇಸವಿಯಲ್ಲಿ ಶಿವಮೊಗ್ಗೆಯ ಇಬ್ಬರು ವಕೀಲರು ಕರ್ನಾಟಕದ ಹೈಕೋರ್ಟಿನಲ್ಲಿ ಒಂದು ಸಾರ್ವಜನಿಕ ಹಿತಾಸಕ್ತಿಯ ದಾವೆ ಹೂಡಿದ್ದರು. ಕೆಎಫ್‌ಡಿಯನ್ನು ನಿಯಂತ್ರಿಸಲು ಸರ್ಕಾರ ಸಾಕಷ್ಟು ಪ್ರಯತ್ನಗಳನ್ನು ನಡೆಸಿಲ್ಲ ಎಂದು ವಾದಿಸಿದ್ದರು. ಈ ವಕೀಲರು ಮಾಡಿದ ಆರು ಮನವಿಗಳಲ್ಲಿ, ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಗಳು ಇನ್ನಷ್ಟು ಹೆಚ್ಚು ಪ್ರದೇಶಗಳಲ್ಲಿ ದೊರೆಯುವಂತೆ ಮಾಡಬೇಕೆನ್ನುವುದೂ ಸೇರಿತ್ತು. 

ವಿಪರ್ಯಾಸವೆಂದರೆ, ಗುಣಮಟ್ಟ ಪ್ರಶ್ನಾರ್ಹವೆನ್ನಿಸಿದ ಮೇಲೂ ಲಸಿಕೆಗಳ ಬಳಕೆಯನ್ನು ಕರ್ನಾಟಕ ಸರಕಾರದ ಆರೋಗ್ಯ ಇಲಾಖೆ ಮುಂದುವರೆಸುವುದರಲ್ಲಿ ಇಂತಹ ಸಾರ್ವಜನಿಕರ ಬೇಡಿಕೆ ಹಾಗೂ ಒತ್ತಾಯದ ಪಾತ್ರವೂ ಇರಬಹುದು. 

ಲಸಿಕೆಗಳ ತಯಾರಿಕೆಯ ಆರಂಭ 

ಕೆಎಫ್‌ಡಿ ನಿಯಂತ್ರಣಕ್ಕೆ ಲಸಿಕೆಯ ಅಗತ್ಯವನ್ನು ಮನಗಂಡ ಕರ್ನಾಟಕ ಸರಕಾರವು 1989ರಲ್ಲಿಯೇ ಶಿವಮೊಗ್ಗದಲ್ಲಿದ ವಿ.ಡಿ.ಎಲ್‌ ನಲ್ಲಿಯೇ ಒಂದು ಲಸಿಕೆ ತಯಾರಿಕೆಯ ಘಟಕವನ್ನು ಸ್ಥಾಪಿಸಿತು. ಎನ್‌.ಐ.ವಿಯು ಸಿ.ಎನ್‌ ದಂಡವತೆಯವರು ರೂಪಿಸಿದ ತಂತ್ರಜ್ಞಾನವನ್ನು ಈ ಘಟಕಕ್ಕೆ ವರ್ಗಾಯಿಸಿ, ಒಂದು ದಶಕದವರೆಗೂ ಲಸಿಕೆಯ ತಯಾರಿಕೆಗೆ ನೆರವು ನೀಡಿತು. ಇದೇ ಅವಧಿಯಲ್ಲಿ ದಂಡವತೆಯವರ ತಂಡ ಲಸಿಕೆಯ ಕ್ಷಮತೆಯನ್ನು ವಿಶ್ಲೇಷಿಸಲು ಎರಡನೆಯ ಕ್ಷೇತ್ರಾಧ್ಯಯನವನ್ನೂ ಕೈಗೊಂಡಿತ್ತು. ಒಂದು ಡೋಸಿನ ನಂತರ ಲಸಿಕೆ 79.3% ಹಾಗೂ ಎರಡು ಡೋಸುಗಳ ನಂತರ 93.5% ಪ್ರಭಾವಿಯಾಗಿರುತ್ತದೆ ಎಂದು ಅವರು ಪತ್ತೆ ಮಾಡಿದ್ದು ಹೀಗೆ. ಇವು ಸಂತಸ ತರುವಂತಹ ಫಲಗಳು.

ವಿ.ಡಿ.ಎಲ್‌ ಲಸಿಕೆಯನ್ನು ಬಹಳ ಕಾಲ ತಯಾರಿಸಲಿಲ್ಲವೆನ್ನಿ. 2000 ಇಸವಿಯಲ್ಲಿ ಕರ್ನಾಟಕ ಸರಕಾರವು ಲಸಿಕೆಯ ತಯಾರಿಕೆಯನ್ನಯ ಐ.ಎ.ಎಚ್‌.ವಿ.ಬಿ ಗೆ ವರ್ಗಾಯಿಸಲು ತೀರ್ಮಾನಿಸಿತು. ವಿ.ಡಿ.ಎಲ್‌ ನಲ್ಲಿ ಸಾಕಷ್ಟು ಸವಲತ್ತುಗಳು ಇಲ್ಲದಿರುವುದು ಇದಕ್ಕೆ ಕಾರಣವಾಗಿತ್ತು. ಹಾಗಿದ್ದರೂ, ಲಸಿಕೆಗಳ ತಯಾರಿಕೆಗೆ ಐ.ಎ.ಎ.ಚ್‌.ವಿ.ಬಿ ತಕ್ಕ ಸ್ಥಳವಾಗಿರಲಿಲ್ಲ. ಅಲ್ಲಿಯವರೆವಿಗೂ, ಈ ಸಂಸ್ಥೆ CDCSO ನಿಯಂತ್ರಣಕ್ಕೆ ನಿಲುಕದ ಪಶುಗಳ ಲಸಿಕೆಯನ್ನಷ್ಟೆ ತಯಾರಿಸುತ್ತಿತ್ತು. ಈ ಸಂಸ್ಥೆಯನ್ನೇ ಸರ್ಕಾರ ಆಯ್ದುಕೊಂಡದ್ದೇಕೆ? ಇದು ಪ್ರಶ್ನೆ.

ಸರಕಾರವು ಲಸಿಕೆಗಳನ್ನು ತಯಾರಿಸಿಕೊಡಿ ಎಂದು ಕೇಳಿದ ಖಾಸಗಿ ಲಸಿಕೆ ತಯಾರಕರು ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಗಳನ್ನು ತಯಾರಿಸಲು ಆಸಕ್ತಿ ತೋರಲಿಲ್ಲವೆನ್ನುವುದು ಇದಕ್ಕೆ ಒಂದು ಉತ್ತರ. ಸೀಮಿತ ಪ್ರದೇಶದಲ್ಲಿಯಷ್ಟೆ ಖಾಯಿಲೆ ಇದ್ದುದರಿಂದ ಸೋಂಕಿನ ಸಾಧ್ಯತೆಗಳನ್ನು ಕಡಿಮೆ ಮಾಡಲು ವಾರ್ಷಿಕ ಒಂದರಿಂದ ಐದು ಲಕ್ಷ ಡೋಸುಗಳಷ್ಟು ಲಸಿಕೆಯನ್ನು ತಯಾರಿಸಲಾಗುತ್ತಿತ್ತು. ಇಷ್ಟು ಸಣ್ಣ ಪ್ರಮಾಣದ ಉತ್ಪಾದನೆಯು ಖಾಸಗಿ ತಯಾರಕರಿಗೆ ಲಾಭದಾಯಕವೆನ್ನಿಸಲಿಲ್ಲ ಎನ್ನುತ್ತಾರೆ ಮಿಂಟ್‌ ಜೊತೆ ಮಾತನಾಡಿದ ಆರೋಗ್ಯ ಇಲಾಖೆಯ ಅಧಿಕಾರಿಗಳು. “ಯಾರಾದರೂ ಮುಂದೆ ಬಂದಿದ್ದರೆ ನಾವೇ ಅವರಿಗೆ ತಯಾರಿಕೆಯನ್ನು ಒಪ್ಪಿಸುತ್ತಿದ್ದೆವು. ಆದರೆ ಯಾರೂ ಇದಕ್ಕೆ ತಯಾರಿರಲಿಲ್ಲ.” ಎಂದು ಜೂನ್‌ ತಿಂಗಳಲ್ಲಿ ನಡೆದ ಸಂದರ್ಶನದಲ್ಲಿ ವಿಡಿಎಲ್‌ ಪ್ರಯೋಗಾಲಯದ ಉಪ ಮುಖ್ಯ ವೈದ್ಯಾಧಿಕಾರಿ ಕೆ. ಜೆ. ಹರ್ಷವರ್ಧನ್‌ ಹೇಳಿದ್ದಾರೆ. ಈ ಎಲ್ಲ ಎಡರುತೊಡರುಗಳ ನಡುವೆಯೂ ಐ.ಎ.ಎಚ್‌.ವಿ.ಬಿಯು 2000ನೇ ಇಸವಿಯಲ್ಲಿ ಲಸಿಕೆಯನ್ನು ತಯಾರಿಸಲು ಆರಂಭಿಸಿತು. ಇದಕ್ಕಾಗಿ ಸಿ.ಡಿ.ಎಸ್‌.ಸಿ.ಓ ಹಾಗೂ ಕರ್ನಾಟಕ ಸರಕಾರದ ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆಗಳೆರಡರ ಪರವಾನಿಗಿಯನ್ನೂ ಪಡೆದಿತ್ತು. ಮಿಂಟ್‌ ಪರಿಶೀಲಿಸಿದ ದಾಖಲೆಗಳ ಪ್ರಕಾರ ಈ ಪರವಾನಿಗಿ ಅಥವಾ ಲೈಸೆನ್ಸು ಡಿಸೆಂಬರ್‌ 2001ಕ್ಕೆ ಕೊನೆಗೊಳ್ಳಲಿತ್ತು. 

ಸಿ.ಡಿ.ಎಸ್‌.ಸಿ.ಓ ಯಾವುದೇ ಲಸಿಕೆಯ ತಯಾರಿಕೆಗೆ ಲೈಸೆನ್ಸು ನೀಡುವಾಗಲೂ ಲಸಿಕೆಯ ತಯಾರಿಕೆಯ ವಿಧಾನ ಹಾಗೂ ತಯಾರಕರು ಪ್ರತಿಯೊಂದು ತಂಡದ ಔಷಧದ ಗುಣಮಟ್ಟ ನಿಯಂತ್ರಣದ ಪರೀಕ್ಷೆಗೂ ಸೇರಿಯೇ ಲೈಸೆನ್ಸು ನೀಡುತ್ತದೆ. ಒಮ್ಮೆ ಹೀಗೆ ಪರವಾನಿಗಿ ಕೊಟ್ಟ ಮೇಲೆ, ಒಂದು ವೇಳೆ ಲಸಿಕೆ ತಯಾರಕರೇನಾದರೂ ಗುಣಮಟ್ಟದ ಪರೀಕ್ಷೆಯಲ್ಲಿ ತೇರ್ಗಡೆಯಾಗದ ಲಸಿಕೆಯನ್ನು ಬಿಡುಗಡೆ ಮಾಡಿದರೆ, ಅದು ಭಾರತೀಯ ಔಷಧ ನಿಯಂತ್ರಣ ಕಾನೂನುಗಳ ಉಲ್ಲಂಘನೆ ಎನಿಸುತ್ತದೆ. 

ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ತಯಾರಿಕೆಯ ವಿಧಾನ ಹೀಗಿದೆ. ಮೊದಲಿಗೆ ಐ.ಎ.ಎಚ್‌.ವಿ.ಬಿಯು ಎನ್‌.ಐ.ವಿಯಿಂದ 1957ರಲ್ಲಿ ಸಂಗ್ರಹಿಸಿದ ವೈರಸ್‌ ತಳಿಯನ್ನು ಪಡೆಯುತ್ತದೆ. ಇದನ್ನು ಮಾಸ್ಟರ್‌ ಸೀಡ್‌, ಮೂಲಬೀಜ ಎನ್ನುತ್ತಾರೆ. ಈ ವೈರಸ್‌ ಮೂಲಬೀಜವನ್ನು ಇಲಿಗಳಲ್ಲಿ ಒಮ್ಮೆ ಕೃಷಿ ಮಾಡಿ ಸಂಖ್ಯೆ ಹೆಚ್ಚಿಸಲಾಗುತ್ತದೆ. ಹೀಗೆ ದೊರೆಯುವ ಅಸಂಖ್ಯ ವೈರಸ್ಸುಗಳನ್ನು ಕಾರ್ಯಾನುಕೂಲಿ ಬೀಜ ಅಥವಾ ವರ್ಕಿಂಗ್‌ ಸೀಡ್‌ ಎನ್ನುತ್ತಾರೆ.  

ಅನಂತರ ಇನ್ನೂ ಒಂದು ಬಾರಿ ಈ ವರ್ಕಿಂಗ್‌ ಸೀಡ್‌ ವೈರಸ್ಸುಗಳನ್ನು ಕೋಳಿಮರಿಯ ಭ್ರೂಣಗಳಲ್ಲಿ ಬೆಳೆಸಲಾಗುತ್ತದೆ. ತದನಂತರ, ಐಎಎಚ್‌ವಿಬಿಯು ಫಾರ್ಮಾಲಿನ್‌ ಬಳಸಿ ಈ ವೈರಸ್ಸುಗಳನ್ನು ನಿಶ್ಶಕ್ತಗೊಳಿಸುತ್ತದೆ. ಹೀಗೆ ದೊರೆತ ಲಸಿಕೆಯನ್ನು ಐಎಎಚ್‌ವಿಬಿಯು ಶುದ್ಧಗೊಳಿಸಿ, ಬಾಟಲಿಗಳಲ್ಲಿ ತುಂಬಿಡುತ್ತದೆ.

ಮುಂದಿನದೇ ಗುಣಮಟ್ಟ ಪರೀಕ್ಷಿಸುವ ಕೊನೆಯ ಹಂತ. ಸಿಡಿಎಸ್‌ಸಿಓ ಪ್ರಕಾರ ಲಸಿಕೆಗಳ ಮೇಲೆ ನಡೆಸಬೇಕಾದ ಪರೀಕ್ಷೆಗಳಲ್ಲಿ ಪೊಟೆನ್ಸಿ ಪರೀಕ್ಷೆ ಅಥವಾ ಕ್ಷಮತೆಯ ಪರೀಕ್ಷೆಯೂ ಒಂದು. ಪೊಟೆನ್ಸಿ ಪರೀಕ್ಷೆಯನ್ನು ನಡೆಸುವ ಕ್ರಮ ಹಾಗೂ ಅದರಲ್ಲಿ ಪ್ರತಿಯೊಂದು ಲಸಿಕೆಯ ತಂಡವೂ ತೇರ್ಗಡೆಯಾಗಬೇಕಾದರೆ ನಿಗದಿಪಡಿಸಿದ ಕನಿಷ್ಠ ಸಾಮರ್ಥ್ಯದ ಮಟ್ಟವನ್ನೂ ಸಿಡಿಎಸ್‌ಸಿಓ ಒಪ್ಪಿ ಪರವಾನಿಗಿ ನೀಡಿತ್ತು. ಸಿಡಿಎಸ್‌ಸಿಓ ಪರವಾನಿಗಿ ನೀಡಿದ ಪರೀಕ್ಷಾ ಕ್ರಮವನ್ನು ಸ್ಥೂಲವಾಗಿ ಹೀಗೆ ವಿವರಿಸಬಹುದು. ಮೊದಲಿಗೆ ತಂತ್ರಜ್ಞರೊಬ್ಬರು ಇಲಿಗಳ ಒಂದು ಗುಂಪಿಗೆ ಮೂರು ದಿನಗಳ ಅಂತರದಲ್ಲಿ ಎಂಬಂತೆ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ಎರಡು ಡೋಸುಗಳನ್ನು ಚುಚ್ಚಬೇಕು. ಏಳು ದಿನಗಳ ನಂತರ ಹೀಗೆ ಲಸಿಕೆ ಪಡೆದ ಇಲಿಗಳು ಹಾಗೂ ಇದೇ ತೆರನ ಆದರೆ ಲಸಿಕೆ ಪಡೆಯದ ಕಂಟ್ರೋಲು ಎನ್ನುವ ಇಲಿಗಳ ಗುಂಪಿಗೆ ಜೀವಂತ ಕೆಎಫ್‌ಡಿ ವೈರಸ್ಸನ್ನು ಚುಚ್ಚಬೇಕು.

ಈ ಎರಡೂ ಗುಂಪುಗಳಲ್ಲಿ ಎಷ್ಟು ಇಲಿಗಳು ಸಾಯುತ್ತವೆ ಎಂಬುದನ್ನು ಗಮನಿಸಿ, ತಂತ್ರಜ್ಞನು ಅದರ ಕನಿಷ್ಠ ಸಾಮರ್ಥ್ಯಕ್ಕಿಂತಲೂ ಹೆಚ್ಚಿರಬೇಕು.

ಕಣ್ಮರೆಯಾದ ಸಿಡಿಎಸ್‌ಸಿಓ

2001ನೇ ಇಸವಿಯ ಡಿಸೆಂಬರಿನಿಂದಲೇ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ತಯಾರಿಕೆ ಹಾದಿ ತಪ್ಪಿತ್ತು. ಆಗ ಐಎಎಚ್‌ವಿಬಿಗೆ ದೊರೆತಿದ್ದ ಮೊದಲ ಪರವಾನಿಗಿ ಕೊನೆಗೊಂಡಿತ್ತು. ಈ ಸಂದರ್ಭದಲ್ಲಿ, ಸಂಸ್ಥೆಯು 2002ರಿಂದ 2006ರವರೆಗಿನ ಮುಂದಿನ ಐದು ವರ್ಷಗಳ ಅವಧಿಗೆ ಪರವಾನಿಗಿಯನ್ನು ನವೀಕರಿಸಬೇಕೆಂದು ಕರ್ನಾಟಕ ರಾಜ್ಯ ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆಗೆ ಅರ್ಜಿ ಸಲ್ಲಿಸಿತು.

ಗಮನಿಸಬೇಕಾದ ಸಂಗತಿಯೇನೆಂದರೆ ಭಾರತ ಸರಕಾರದ ಜಂಟೀ ಪರವಾನಿಗಿ ವ್ಯವಸ್ಥೆಯಲ್ಲಿ ಉತ್ಪಾದನೆ ನಡೆಯುತ್ತಿರುವ ರಾಜ್ಯದ ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆಯೇ ಪರವಾನಿಗಿ ನೀಡುತ್ತದೆ. ಆದರೆ ಅದು ಸಿಡಿಎಸ್‌ಸಿಓ ಅನುಮತಿ ನೀಡದಿದ್ದರೆ ಮುಂದುವರೆಯುವಂತಿಲ್ಲ.

ಆದರೆ ಐಎಎಚ್‌ವಿಬಿಯ ಅರ್ಜಿಗೆ ಕರ್ನಾಟಕ ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆ ಉತ್ತರಿಸಲಿಲ್ಲ ಎಂದು ಐಎಎಚ್‌ವಿಬಿಯಲ್ಲಿ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆ ತಯಾರಿಕೆಯ ಮೇಲ್ವಿಚಾರಣೆ ನೋಡಿಕೊಳ್ಳುವ ವಿಜ್ಞಾನಿ ಬಿ. ಎಂ. ಚಂದ್ರಾನಾಯಕ್‌ ಆಗಸ್ಟ್‌ ತಿಂಗಳಲ್ಲಿ ಮಿಂಟ್‌ ಪತ್ರಿಕೆಗೆ ತಿಳಿಸಿದರು. ಹಾಗಿದ್ದೂ ಐಎಎಚ್‌ವಿಬಿ ಔಷಧ ಮತ್ತು ಔಷಧೀಯ ವಸ್ತುಗಳ ನಿಯಂತ್ರಣ ಕಾಯಿದೆಯಲ್ಲಿರುವ ಲೋಪವೊಂದರ ಲಾಭ ಪಡೆದು ಲಸಿಕೆಗಳ ತಯಾರಿಕೆಯನ್ನು ಮುಂದುವರೆಸಿತು. ಲೈಸೆನ್ಸು ಚಾಲ್ತಿಯಲ್ಲಿರುವಾಗಲೇ ತಯಾರಕರು ನವೀಕರಣಕ್ಕೆ ಅರ್ಜಿ ಹಾಕಿದ್ದ ಸಂದರ್ಭದಲ್ಲಿ, ಅರ್ಜಿಯನ್ನು ಕ್ವಚಿತ್ತಾಗಿ ನಿರಾಕರಿಸುವವರೆಗೂ ಲೈಸೆನ್ಸು ಚಾಲ್ತಿಯಲ್ಲಿದೆ ಎಂದು ಭಾವಿಸಬಹುದು ಎನ್ನುವುದೇ ಈ ಲೋಪ.

ಐಎಎಚ್‌ವಿಬಿಯು ಮುಂದೆ ಲೈಸೆನ್ಸು ಮುಗಿದಿದ್ದು ನವೀಕರಣಕ್ಕೆ ಮೂರು ಬಾರಿ ಅರ್ಜಿ ಸಲ್ಲಿಸಿತ್ತು. ಈ 2002-2006, 2007-2011 ಹಾಗೂ 2012-2016ರ ಮೂರು ಅವಧಿಗೆ ಲೈಸೆನ್ಸು ನವೀಕರಣಕ್ಕೆ ಅರ್ಜಿ ಸಲ್ಲಿಸಿದ ಸಂದರ್ಭದಲ್ಲಿಯೂ ಇದೇ ಸ್ಥಿತಿ ಮರುಕಳಿಸಿತ್ತು. ಅಂದರೆ ಪ್ರತಿಬಾರಿ ಐಎಎಚ್‌ವಿಬಿ ಲೈಸೆನ್ಸು ನವೀಕರಣಕ್ಕೆ ಅರ್ಜಿ ಸಲ್ಲಿಸಿದಾಗಲೂ, ಕರ್ನಾಟಕ ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆ ಸ್ಪಂದಿಸಲಿಲ್ಲ. ಹಾಗಿದ್ದೂ, ಐಎಎಚ್‌ವಿಬಿ ಲಸಿಕೆಯ ತಯಾರಿಕೆಯನ್ನು ಮುಂದುವರೆಸಿತ್ತು.

ಚಂದ್ರಾನಾಯಕರ ಪ್ರಕಾರ ಕೊನೆಗೂ ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆಯು ಕಂಪೆನಿಯ ಅರ್ಜಿಗೆ 2020ರಲ್ಲಿಯಷ್ಟೆ ಸ್ಪಂದಿಸಿತು. ಈಗ ಇಲಾಖೆಯು ಕಂಪೆನಿಗೆ ಪೂರ್ವಾನ್ವಯವಾಗುವಂತೆ ಎರಡು ಅವಧಿಯ ಲೈಸೆನ್ಸನ್ನು (2007-2011 ಹಾಗೂ 2012-2016 ಅವಧಿಗೆ) ಹಾಗೂ ಪ್ರಸ್ತುತ ಅವಧಿಗೆ (2017-2021) ಅನ್ವಯಿಸುವ ಒಂದು ಕೂಡಿ ಮೂರೂ ಲೈಸೆನ್ಸನ್ನೂ ಒಮ್ಮೆಲೇ ಕಳಿಸಿತು.

ತಡವಾಗಿ ಹೀಗೆ ದೊರೆತ ಲೈಸೆನ್ಸುಗಳು ಪರಿಸ್ಥಿತಿಯನ್ನು ಇನ್ನಷ್ಟು ಜಟಿಲಗೊಳಿಸಿದುವು. ವಿಚಿತ್ರವೆಂದರೆ, ಮೂರೂ ಲೈಸೆನ್ಸುಗಳಲ್ಲಿಯೂ, ಐಎಎಚ್‌ವಿಬಿಗೆ ತಯಾರಿಸಲು ಲೈಸೆನ್ಸು ನೀಡಿದ ಉತ್ಪನ್ನಗಳ ಪಟ್ಟಿಯಲ್ಲಿದ್ದ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ಹೆಸರನ್ನು ಸಿಡಿಎಸ್‌ಸಿಓ ಸ್ಪಷ್ಟವಾಗಿ ಅಳಿಸಿ ಹಾಕಿತ್ತು. ಅಂದರೆ, ಸಿಡಿಎಸ್‌ಸಿಓ ಲಸಿಕೆಯನ್ನು ತಯಾರಿಸಲು ಕಂಪೆನಿಗೆ ನೀಡಿದ್ದ ಅನುಮತಿಯನ್ನು ಪೂರ್ವಾನ್ವಯವಾಗುವಂತೆ ರದ್ದುಗೊಳಿಸಿತ್ತು.

ಸಿಡಿಎಸ್‌ಸಿಓ ಲೈಸೆನ್ಸುಗಳನ್ನು ರದ್ದುಗೊಳಿಸಿದ್ದರೂ ಲಸಿಕೆಯನ್ನು ತಯಾರಿಸಲು ಐಎಎಚ್‌ವಿಬಿಗೆ ಬಿಟ್ಟಿದ್ದು ಏಕೆಂದು ಕರ್ನಾಟಕ ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆಯ ಅಧಿಕಾರಿಗಳನ್ನು ಮಿಂಟ್‌ ಪ್ರಶ್ನಿಸಿತು. ಸೆಪ್ಟೆಂಬರ್‌ 2022ರಲ್ಲಿ ನಡೆದ ಸಂದರ್ಶನದಲ್ಲಿ ಅಧಿಕಾರಿಗಳು ಹೆಸರನ್ನು ಅಳಿಸಿ ಹಾಕಿದ್ದು ಸಿಡಿಎಸ್‌ಸಿಓ ಎಂದೂ, ಅದರ ಅರ್ಥವೇನೆಂದು ತಮಗೆ ತಿಳಿಯಲಿಲ್ಲವೆಂದೂ ಹೇಳಿದ್ದಾರೆ. ಕರ್ನಾಟಕದ ಔಷಧ ನಿಯಂತ್ರಣಾಧಿಕಾರಿ ಭಾಗೋಜಿ ಖಾನಾಪುರೆ, ತಾವು 2020ರಿಂದೀಚೆಗೆ ಹಲವು ಬಾರಿ ಸಿಡಿಎಸ್‌ಸಿಓದ ಮುಖ್ಯಸ್ಥರಾದ ಶ್ರೀ ವಿ. ಜಿ. ಸೋಮಾನಿಯವರನ್ನು ಹಾಗೆಂದರೇನೆಂದು ಕೇಳಿದ್ದಾಗಿ ತಿಳಿಸಿದ್ದಾರೆ. ಆದರೆ ಸೋಮಾನಿಯವರು ಉತ್ತರಿಸಲೇ ಇಲ್ಲ. “ಅವರಿಗೇ ಅದರ ಅರ್ಥ ಗೊತ್ತಿಲ್ಲವೆನ್ನಿಸುತ್ತದೆ.”

ಸೋಮಾನಿಯವರಿಂದ ಯಾವುದೇ ಉತ್ತರ ಬಾರದಿದ್ದದ್ದೂ, ಸಿಡಿಎಸ್‌ಸಿಓ ಕೂಡ ಲೈಸೆನ್ಸುಗಳನ್ನು ರದ್ದು ಮಾಡಲು ಕಾರಣಗಳನ್ನು ತಿಳಿಸದ್ದರಿಂದ, ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆ ಲೈಸೆನ್ಸುಗಳು ಸಕ್ರಮವೆಂದು ಭಾವಿಸಿದರು.

ಖಾನಾಪುರೆಯವರ ಈ ವಿವರಣೆ ವಿವಾದಾಸ್ಪದ. ಏಕೆಂದರೆ 2006ರಿಂದ ಆರಂಭಿಸಿ ಲೈಸೆನ್ಸಿನಿಂದ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ಹೆಸರನ್ನು ಸಿಡಿಎಸ್‌ಸಿಓ ಅಳಿಸಿಹಾಕಿದ ಅವಧಿಯಲ್ಲಿ ಸಿಡಿಎಸ್‌ಸಿಓ ಲೈಸೆನ್ಸುದಾಯಕ ಸಂಸ್ಥೆಯ ಯಾವ ಕರ್ತವ್ಯವನ್ನೂ ನಿರ್ವಹಿಸಿರಲಿಲ್ಲವೆಂದು ಮಿಂಟ್‌ ಪತ್ತೆ ಮಾಡಿದೆ.

ಉದಾಹರಣೆಗೆ, ಭಾರತದಲ್ಲಿ ಮಾರಾಟವಾಗುವ ಲೈಸೆನ್ಸು ಪಡೆದ ಲಸಿಕೆಗಳು ಪ್ರತಿಯೊಂದರ, ಪ್ರತಿ ತಂಡವನ್ನೂ ಅದು ಜನತೆಯನ್ನು ಮುಟ್ಟುವ ಮೊದಲು ಹಿಮಾಚಲ ಪ್ರದೇಶದ ಕಸೌಲಿಯಲ್ಲಿ ಇರುವ ಸಿಡಿಎಸ್‌ಸಿಓಗೆ ಸೇರಿದ ಸೆಂಟ್ರಲ್‌ ಡ್ರಗ್ಸ್‌ ಪ್ರಯೋಗಾಲಯವು ಗುಣಮಟ್ಟಕ್ಕಾಗಿ ಪರೀಕ್ಷಿಸುತ್ತದೆ. ಆದರೆ, ಕಸೌಲಿಯ ಪ್ರಯೋಗಾಲಯಕ್ಕೆ ಮಾಹಿತಿ ಹಕ್ಕು ಕಾಯ್ದೆಯಡಿಯಲ್ಲಿ ಈ ಬಗ್ಗೆ ಪ್ರಶ್ನಿಸಿದಾಗ, ಪ್ರಯೋಗಾಲಯವು ತಾನು ಎಂದೂ ಕೆಏಫ್‌ಡಿ ಲಸಿಕೆಯನ್ನು ಪರೀಕ್ಷಿಸಿಲ್ಲವೆಂದು ಮಿಂಟ್‌ ಗೆ ಉತ್ತರಿಸಿದೆ..

ಅಷ್ಟೇ ಅಲ್ಲ. ಸಿಡಿಎಸ್‌ಸಿಓದ ಜಾಲತಾಣದಲ್ಲಿ ಪ್ರಕಟವಾಗಿರುವ ದಾಖಲೆಯೊಂದು, ಕನಿಷ್ಠ 2009ರಿಂದ ಈಚೆಗೆ ಐಎಎಚ್‌ವಿಬಿಯನ್ನು ಮಾನವಬಳಕೆಗೆ ಬಳಸುವ ಲಸಿಕೆಗಳ ತಯಾರಕನೆಂದು ಪರಿಗಣಿಸುವುದನ್ನು ಸಿಡಿಎಸ್‌ಸಿಓ ನಿಲ್ಲಿಸಿತ್ತು ಎಂದು ಸೂಚಿಸುತ್ತದೆ. 2009ರಿಂದ ಸಿಡಿಎಸ್‌ಸಿಓ ಪರವಾನಿಗಿ ನೀಡಿರುವ ಮಾನವ ಲಸಿಕೆಗಳ ತಯಾರಕರ ಪಟ್ಟಿ ಯಲ್ಲಿ ಐಎಎಚ್‌ವಿಬಿಯ ಉಲ್ಲೇಖವೇ ಇಲ್ಲ. ಈ ಬಗ್ಗೆ ಮಿಂಟ್‌ ಕೇಳಿದ ಪ್ರಶ್ನೆಗಳಿಗೆ ಸಿಡಿಎಸ್‌ಸಿಓದ ಮುಖ್ಯಸ್ಥರಾದ ಶ್ರೀ ಸೋಮಾನಿ ಉತ್ತರಿಸಲಿಲ್ಲ.

ಸಾಮರ್ಥ್ಯ ಕುಗ್ಗಿದ ಲಸಿಕೆಗಳು

ಸಿಡಿಎಸ್‌ಸಿಓ ಹೀಗೆ ತನ್ನ ಹೊಣೆಗಾರಿಕೆಯನ್ನು ನಿಭಾಯಿಸದಿದ್ದಾಗ, ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ಗುಣಮಟ್ಟ ಕುಸಿಯಿತು. ಗುಣಮಟ್ಟದ ಸಮಸ್ಯೆಗಳನ್ನು ಹತ್ತಿಕ್ಕಲು, ಎನ್‌ಐವಿಗೆ ಬೃಹತ್‌ ಪ್ರಮಾಣದ ತಯಾರಿಕೆಯ ಅನುಭವವಿಲ್ಲದಿದ್ದರೂ ಅದರ ಸಲಹೆಯನ್ನು  ಕರ್ನಾಟಕ ಆರೋಗ್ಯ ಇಲಾಖೆಯು ಕೇಳಿತು. ಹೀಗಾಗಿ ಎನ್‌ಐವಿ ಇದಕ್ಕೆ ನೀಡಿದ ಸಲಹೆಯೂ ಪ್ರಶ್ನಾರ್ಹವೇ.

ಈ ಎಲ್ಲ ಸಮಸ್ಯೆಗಳ ಮೊದಲ ಸುಳಿವುಗಳನ್ನು ಕರ್ನಾಟಕ ಆರೋಗ್ಯ ಇಲಾಖೆಯು 2012ರಲ್ಲಿ ನಡೆಸಿದ ಸಭೆಯೊಂದರ ನಡಾವಳಿಯಲ್ಲಿ ಕಾಣಬಹುದು. ಅಕ್ಟೋಬರ್‌ 4ರಂದು ಜರುಗಿದ ಈ ಸಭೆಯಲ್ಲಿ ಐಎಎಚ್‌ವಿಬಿಯ ಹಿರಿಯ ಪ್ರತಿನಿಧಿಗಳೂ, ಕರ್ನಾಟಕ ಔಷಧ ನಿಯಂತ್ರಣ ಇಲಾಖೆಯಲ್ಲಿ ಅಂದು ಅಪರ ಔಷಧ ನಿಯಂತ್ರಕರಾಗಿದ್ದ ರಘುರಾಮ್‌ ಭಂಡಾರಯವರೂ ಇದ್ದರು. ಐಎಎಚ್‌ವಿಬಿಗೆ ಲಸಿಕೆಯ ಗುಣಮಟ್ಟದ ಅಂತಿಮ ಪರೀಕ್ಷೆಗೆ ನೆರವಾಗುತ್ತಿದ್ದ, ಶಿವಮೊಗ್ಗೆಯ ಸರಕಾರಿ ವೈರಸ್‌ ಪತ್ತೆ ಪ್ರಯೋಗಾಲಯ (ವಿಡಿಎಲ್‌) ಕೆಲವು ಅಧಿಕಾರಿಗಳೂ ಸಭೆಯಲ್ಲಿದ್ದರು.

ಆರೋಗ್ಯ ಇಲಾಖೆಯ ಜಂಟಿ ನಿರ್ದೇಶಕರು ಸಭೆಯನ್ನು ಆರಂಭಿಸಿದರು. ಸಭಾಸದರನ್ನು ಸ್ವಾಗತಿಸಿದ ನಂತರ ಆತ, ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ಇತ್ತೀಚಿನ ತಂಡದ ಗುಣಮಟ್ಟ “ಸ್ವಲ್ಪ ಕಡಿಮೆ” ಇದೆ ಎಂದು ತಿಳಿಸಿದರು. ಆದರೆ, ಮುಂದುವರೆದು, “ತುರ್ತು ಅವಶ್ಯಕತೆಗಳಿಂದಾಗಿ” ಸಭೆ ಈ ಲಸಿಕೆಯ ಬಿಡುಗಡೆಯನ್ನು ಮಾನ್ಯ ಮಾಡಬೇಕೆಂದು ವಿನಂತಿಸಿದರು. ಈ “ತುರ್ತು” ಇನ್ನೇನಲ್ಲ. ಕೆಎಫ್‌ಡಿ ಸೋಂಕಿನ ಋತು ಆರಂಭವಾಗಲು ಒಂದು ತಿಂಗಳಷ್ಟೆ ಉಳಿದಿತ್ತು. ಸಭೆಯಲ್ಲಿದ್ದವರು ಇದಕ್ಕೆ ಒಪ್ಪಿದರು ಎಂದು ನಡಾವಳಿ ತಿಳಿಸುತ್ತದೆ. ಮಿಂಟ್‌ ಭಂಡಾರಿಯವರನ್ನೂ ಸೇರಿದಂತೆ ಸಭೆಯಲ್ಲಿ ಭಾಗವಹಿಸಿದವರಲ್ಲಿ ಐವರನ್ನು ಹೀಗೆ ಸಾಮರ್ಥ್ಯ ಕುಂದಿದ ಲಸಿಕೆಯನ್ನು ಬಳಸಲು ಹೇಗೆ ಒಪ್ಪಿಗೆ ನೀಡಿದಿರಿ, ಅದು ಕಾನೂನುಬಾಹಿರವಲ್ಲವೇ ಎಂದು ಪ್ರಶ್ನಿಸಿತು. ಯಾರೂ ಉತ್ತರಿಸಲು ಒಪ್ಪಲಿಲ್ಲ.

ಅನಂತರ ಜಂಟಿ ನಿರ್ದೇಶಕರು ಇನ್ನೊಂದು ವಿನಂತಿ ಮಾಡಿದರು. ಎನ್‌ಐವಿಯ ಹಿರಿಯ ವೈರಸ್‌ ವಿಜ್ಞಾನಿ ದೇವೆಂದ್ರ ಟಿ. ಮೌರ್ಯ ಐಎಎಚ್‌ವಿಬಿಯು ಲಸಿಕೆಯ ಸಾಮರ್ಥ್ಯವನ್ನು ಅಳೆಯಲು ಇಲಿಗಳಲ್ಲಿ ಮಾಡುತ್ತಿದ್ದ ಪರೀಕ್ಷೆಗಳಲ್ಲಿ ಒಂದು “ಪುಟ್ಟ ಬದಲಾವಣೆ” ಮಾಡಲು ಸಲಹೆ ನೀಡಿದ್ದಾರೆಂದು ತಿಳಿಸಿದರು. ಮೌರ್ಯ ಆಗ ಎನ್‌ಐವಿಯ ಅತ್ಯುನ್ನತ ಶ್ರೇಣಿಯ ವಿಜ್ಞಾನಿಗಳಲ್ಲೊಬ್ಬರು. ವೈರಸ್‌ ರೋಗಾಣುಗಳ ಬಗ್ಗೆ ವ್ಯಾಪಕವಾಗಿ ಸಂಶೋಧನೆ ಮಾಡಿದ್ದರು. ಮರುವರ್ಷವೇ ಅವರು ಎನ್‌ಐವಿಯ ನಿರ್ದೇಶಕರೂ ಆಗುವವರಿದ್ದರು. ಜಂಟಿ ನಿರ್ದೇಶಕರು ಮೌರ್ಯ ಅವರು ಸೂಚಿಸಿದ ಬದಲಾವಣೆಗಳನ್ನು ಕುರಿತು ಪರಿಣತರ ಇನ್ನೊಂದು ಉಪಸಮಿತಿ ಬೇಕು ಎಂದರು.

ಐಎಎಚ್‌ವಿಬಿಯ ನಿರ್ದೇಶಕರನ್ನೂ ಒಳಗೊಂಡಿದ್ದ ಈ ಉಪಸಮಿತಿಯು ಎರಡು ತಿಂಗಳ ನಂತರ ಅಂದರೆ ಡಿಸೆಂಬರ್‌ 2012ರಂದು ಸಭೆ ಸೇರಿತು. ಈ ಸಭೆಯ ನಡಾವಳಿ ಅಚ್ಚರಿಗಳನ್ನು ತೆರೆದಿಟ್ಟಿದೆ. ಲಸಿಕೆಯ ಸಾಮರ್ಥ್ಯವು ಕುಗ್ಗುತ್ತಿರುವುದಕ್ಕೆ ಲಸಿಕೆಗೆ ಬಳಸಿದ ವೈರಸ್ಸನ್ನು ಕಾಲಾಂತರದಲ್ಲಿ ಹಲವಾರು ಬಾರಿ ಬಳಸಿದ್ದು ಕಾರಣವಿರಬಹುದೆಂದು ಸಮಿತಿಯು ದಾಖಲಿಸಿದೆ.

ಸರಳವಾಗಿ ಹೇಳಬೇಕೆಂದರೆ, ಎನ್‌ಐವಿಯಿಂದ ಪಡೆದ ಮಾಸ್ಟರ್‌ ಬೀಜವನ್ನು ಒಮ್ಮೆ ಇಲಿಯಲ್ಲಿ ಹಾಗೂ ಇನ್ನೊಮ್ಮೆ ಕೋಳಿಮರಿಯ ಭ್ರೂಣದಲ್ಲಿ, ಹೀಗೆ ಎರಡೇ ಬಾರಿ ಸಂಖ್ಯಾಭಿವೃದ್ಧಿ ಮಾಡಬೇಕಿತ್ತಾದರೂ, ಅದನ್ನು ಹಲವಾರು ಬಾರಿ ಸಂಖ್ಯಾಭಿವೃದ್ಧಿಗೆ ಬಳಸಲಾಗಿತ್ತು. ಇದು ಉತ್ತಮ ತಯಾರಿಕಾಕ್ರಮಗಳ ಉಲ್ಲಂಘನೆ. ಹೀಗೆ ಅತಿಯಾಗಿ ವೈರಸ್ಸನ್ನು ಸಂಖ್ಯಾಭಿವೃದ್ಧಿ ಮಾಡುವುದರಿಂದ ಅದರ ತಳಿಗುಣಗಳಲ್ಲಿ ಬದಲಾವಣೆಗಳುಂಟಾಗಿ, ಲಸಿಕೆಯ ಸಾಮರ್ಥ್ಯವನ್ನು ಕುಗ್ಗಿಸುತ್ತದೆ.

ಉಪಸಮಿತಿಯು ಊಹಿಸಿದ ಕಾರಣ ಇದೇ ಆಗಿದ್ದರೆ, ಸಮಸ್ಯೆಯನ್ನು ಪರಿಹರಿಸಲು ಐಎಎಚ್‌ವಿಬಿಗೆ ಇದ್ದ ದಾರಿ ಒಂದೇ. ಎನ್‌ಐವಿಯಿಂದ ಹೊಸ ಮಾಸ್ಟರ್‌ ಸೀಡನ್ನು ತರಿಸಿ, ಹೊಸದಾಗಿ ಲಸಿಕೆಯನ್ನು ತಯಾರಿಸುವುದು. ಬದಲಿಗೆ, ಈ ಸಮಸ್ಯೆಯ ಪರಿಹಾರಕ್ಕೆ ಮೌರ್ಯ ಪರೀಕ್ಷೆಯ ಕ್ರಮವನ್ನೇ ಬದಲಿಸಲು ಸೂಚಿಸಿದರೆಂದು ಸಮಿತಿಯ ನಡಾವಳಿಗಳು ತಿಳಿಸುತ್ತವೆ. ಲೈಸೆನ್ಸು ಪಡೆದ ಲಸಿಕೆಯ ತಯಾರಿಕಾ ಕ್ರಮದಲ್ಲಿ ಸಿಡಿಎಸ್‌ಸಿಓದ ಪೂರ್ವಾನುಮತಿ ಇಲ್ಲದೆ ಇಂತಹ ಬದಲಾವಣೆಗಳನ್ನು ಐಎಎಚ್‌ವಿಬಿ ಮಾಡಬಾರದಿತ್ತು. ಆದರೆ ಮಿಂಟ್‌ ನಡೆಸಿದ ಶೋಧಗಳ ಪ್ರಕಾರ ಸಿಡಿಎಸ್‌ಸಿಓ ಕಂಪೆನಿಯ ಲೈಸೆನ್ಸನ್ನು ಪುನರ್ನವೀಕರಿಸುವುದನ್ನು ನಿಲ್ಲಿಸಿ ಬಹಳ ದಿನಗಳಾಗಿದ್ದುವು.

ಮಿಂಟ್‌ ಮೌರ್ಯ ಅವರಿಗೆ ಇಮೇಲ್‌ ಹಾಗೂ ವಾಟ್ಸಾಪುಗಳ ಮುಖಾಂತರ ಸಂದೇಶಗಳನ್ನು ಕಳಿಸಿ, ವೈರಸ್ಸುಗಳ ಅತಿ ಸಂಖ್ಯಾಭಿವೃದ್ಧಿ ಸಮಸ್ಯೆಗೆ ಅದು ಪರಿಹಾರ ಒದಗಿಸದೆಂದು ತಿಳಿಸಿದ್ದರೂ, ಸಿಡಿಎಸ್‌ಸಿಓ-ಒಪ್ಪಿತ ಕ್ರಮಗಳನ್ನು ಬದಲಿಸಲು ತಾವು ಸೂಚಿಸಿದ್ದೇಕೆ ಎಂದು ಕೇಳಿತ್ತು. ಆದರೆ 2019ನೇ ಇಸವಿಯಲ್ಲಿ ಎನ್‌ಐವಿಯಿಂದ ನಿವೃತ್ತರಾದ ಮೌರ್ಯ ಇದಕ್ಕೆ ಉತ್ತರಿಸಲಿಲ್ಲ.

ಐಎಎಚ್‌ವಿಬಿಗೆ ಇಂತಹ ಪ್ರಶ್ನಾರ್ಹ ಪರಿಹಾರಗಳನ್ನು ಎನ್‌ಐವಿ ನೀಡಿದ್ದು ಇದೇ ಮೊದಲೇನಲ್ಲ. ಇದು 2022ರಲ್ಲಿ ಮರುಕಳಿಸಿತು.

ಲಸಿಕೆಯ ಸಾಮರ್ಥ್ಯ ಕುಸಿಯಿತು

ಐಎಎಚ್‌ವಿಬಿಯು ಲಸಿಕೆಯ ಸಾಮರ್ಥ್ಯ ಕುಸಿಯುತ್ತಿರುವ ಸಮಸ್ಯೆಯ ಜೊತೆಗೆ ಹೋರಾಡುತ್ತಿದ್ದಂತೆಯೇ, ಲಸಿಕೆಯ ಪರಿಣಾಮವೂ ಕಡಿಮೆಯಾಗುತ್ತಿತ್ತು. ಇದರ ಸೂಚನೆಗಳು 2000ನೇ ಇಸವಿಯಲ್ಲಿ ಪ್ರಕಟವಾದ ಸಂಶೋಧನಾ ಪತ್ರಗಳಲ್ಲಿ ಕಾಣಿಸುತ್ತವೆ. 2006ನೇ ಇಸವಿಯಲ್ಲಿ ಗ್ವಾಲಿಯರಿನಲ್ಲಿರುವ ರಕ್ಷಣಾ ಸಂಶೋಧನೆ ಹಾಗೂ ಅಭಿವೃದ್ಧಿ ಸಂಸ್ಥೆಯ ವೈರಸ್‌ ವಿಜ್ಞಾನಿಯೊಬ್ಬರು ಒಂದು ಪರಾಮರ್ಶನ ಪ್ರಬಂಧವನ್ನು ಪ್ರಕಟಿಸಿದ್ದರು. ಇದರಲ್ಲಿ ನಿಯತವಾಗಿ ಲಸಿಕೆಗಳನ್ನು ನೀಡಿದ್ದಾಗ್ಯೂ ಕರ್ನಾಟಕದ ಐದು ಜಿಲ್ಲೆಗಳಲ್ಲಿ ಕೆಎಫ್‌ಡಿ ರೋಗಿಗಳ ಸಂಖ್ಯೆ 1999ರಿಂದ 2004ರವರೆಗೂ ಹೆಚ್ಚುತ್ತಲೇ ಇತ್ತು.

ಏಳು ವರ್ಷಗಳ ನಂತರ ಇದಕ್ಕೆ ಇನ್ನೂ ಸ್ಪಷ್ಟವಾದ ಪುರಾವೆ ದೊರಕಿತು. 2011-12ನೇ ಇಸವಿಯಲ್ಲಿ ಶಿವಮೊಗ್ಗ ಜಿಲ್ಲೆಯಲ್ಲಿ ಕೆಎಫ್‌ಡಿ ಸೋಂಕು ದೊಡ್ಡಮಟ್ಟದಲ್ಲಿ ಕಾಣಿಸಿಕೊಂಡಿತು. ಹೀಗೆ ಖಾಯಿಲೆ ಬಿದ್ದವರಲ್ಲಿ ಎರಡೂ ಡೋಸು ಲಸಿಕೆ ಪಡೆದವ ಹಲವರು ಇದ್ದರು. ಇದು ವಿಚಿತ್ರವೆನ್ನಿಸಿತು. ಏಕೆಂದರೆ 1994ರಲ್ಲಿ ದಂಡವತೆಯವರು ನಡೆಸಿದ ಅಧ್ಯಯನದ ಪ್ರಕಾರ ಎರಡು ಡೋಸು ಲಸಿಕೆಯನ್ನು ನೀಡಿದ ಪರಿಣಾಮ 93.5% ಇರಬೇಕಿತ್ತು.

ಖಾಯಿಲೆ ಹೀಗೆ ಮರುಕಳಿಸುತ್ತಿದ್ದುದು ಸ್ಥಳೀಯರಲ್ಲಿ ಲಸಿಕೆ ಕೆಲಸ ಮಾಡುತ್ತಿಲ್ಲವೆಂಬ ಅನುಮಾನವನ್ನುಂಟು ಮಾಡಿತು.  ಭಾರತೀಯ ವೈದ್ಯಕೀಯ ಸಂಶೋಧನಾ ಮಂಡಳಿಯ ಎನ್‌ಐವಿಯದ್ದೇ ಸೋದರ ಸಂಸ್ಥೆಯಾದ ಚೆನ್ನೈನಲ್ಲಿರುವ ನ್ಯಾಶನಲ್‌ ಇನ್ಸ್‌ಟಿಟ್ಯೂಟ್‌ ಆಫ್‌ ಎಪಿಡೆಮಿಯಾಲಜಿಯ ಮುಖ್ಯಸ್ಥರಾದ ಮನೋಜ್‌ ಮುರ್ರೇಕರ್‌  “ಜಿಲ್ಲೆಯ ಯಾವ ವೈದ್ಯಾಧಿಕಾರಿಯನ್ನು ಕೇಳಿದರೂ, ಲಸಿಕೆಯಿಂದ ಏನೂ ಪ್ರಯೋಜನವಿಲ್ಲ ಎಂದೇ ಹೇಳುತ್ತಿದ್ದರು, (ಆಗ)” ಎಂದು ನೆನಪಿಸಿಕೊಳ್ಳುತ್ತಾರೆ.

ಇದರ ಕಾರಣವೇನೆಂದು ತಿಳಿಯಲು ಮುರ್ರೇಕರರ ತಂಡ ಶಿವಮೊಗ್ಗೆಯ ಆರೋಗ್ಯಾಧಿಕಾರಿಗಳ ಜೊತೆಗೂಡಿ ಲಸಿಕೆಯ ಪರಿಣಾಮದ ಅಧ್ಯಯನವೊಂದನ್ನು ಕೈಗೊಂಡಿತು. 2013ರಲ್ಲಿ ಪ್ರಕಟವಾದ ಈ ಅಧ್ಯಯನದ ವಿವರಗಳು, 2011-12ರ ಸೋಂಕಿನ ವೇಳೆ ಶಿವಮೊಗ್ಗೆಯ ಸ್ಥಳೀಯರಿಗೆ ನೀಡಿದ ಒಂದು ಡೋಸ್‌ ಲಸಿಕೆ ಯಾವುದೇ ರಕ್ಷಣೆಯನ್ನೂ ನೀಡಲಿಲ್ಲವೆಂದು ತಿಳಿಸಿವೆ. ಚಕಿತಗೊಂಡ ತಂಡ ಇನ್ನೊಂದು ಅಧ್ಯಯನವನ್ನು ಕೈಗೊಂಡಿತು. ಈ ಬಾರಿ 2005 ರಿಂದ 2010ರವರೆಗಿನ ಹಳೆಯ ಮಾಹಿತಿಗಳನ್ನು ಪರಿಶೀಲಿಸಿತು. ಇದರಲ್ಲಿಯೂ ಒಂದು ಡೋಸು ಲಸಿಕೆ ಪಡೆದವರಿಗೆ ಯಾವುದೇ ರಕ್ಷಣೆ ದೊರಕಲಿಲ್ಲವೆನ್ನುವುದನ್ನು ತಂಡ ಗಮನಿಸಿತು. ಎರಡು ಡೋಸು ದಂಡವತೆಯವರ ಅಧ್ಯಯನದಲ್ಲಿ ನಮೂದಿಸಿದ್ದ 93.5% ಬದಲಿಗೆ ಕೇವಲ 62.4% ರಕ್ಷಣೆಯಷ್ಟೆ ಸಿಕ್ಕಿತ್ತು.

ಶಿವಮೊಗ್ಗದಲ್ಲಿ, 2013-14 ಸಾಲಿನಲ್ಲಿ ಇನ್ನೊಮ್ಮೆ ಸೋಂಕು ಕಾಣಿಸಿಕೊಂಡಾಗ ಮುರ್ರೇಕರ್‌ ಮತ್ತು ಸಂಗಡಿಗರು ಇನ್ನೊಮ್ಮೆ ಲೆಕ್ಕ ಹಾಕಿದರು. ಫಲಿತಾಂಶ ಬೇರೆಯೇನಿರಲಿಲ್ಲ. ಮೊದಲ ಡೋಸು ಲಸಿಕೆ ರೋಗದಿಂದ ಕಾಪಾಡದಷ್ಟು ನಿಷ್ಪ್ರಯೋಜಕವಾಗಿತ್ತು. ಎರಡನೆಯ ಡೋಸು ನಂಬಿದ್ದಷ್ಟು ಉತ್ತಮವಾಗಿರಲಿಲ್ಲ.

ಹೀಗೆ ಲಸಿಕೆಯ ಪರಿಣಾಮದಲ್ಲಿ ಕುಂದುಂಟಾಗಿದ್ದು ರಾಜ್ಯ ಸರಕಾರಗಳನ್ನು ಅಡಕೊತ್ತರಿಯಲ್ಲಿ ಸಿಕ್ಕಿಸಿದವು. ಮೊದಲೇ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯನ್ನು ನೀಡುವುದು ಕಷ್ಟಕರವಾದ ಕೆಲಸ. ಏಕೆಂದರೆ ಎರಡು ಡೋಸು ಲಸಿಕೆ ನೀಡಿದ ಮೇಲೂ ಪ್ರತಿವರ್ಷ ಬಲವರ್ಧನೆಯ ಇನ್ನೊಂದು ಡೋಸು ಲಸಿಕೆ ನೀಡಬೇಕಾಗುತ್ತದೆ.

ಇವೆಲ್ಲ ಸಾಲದು ಎನ್ನುವ ಹಾಗೆ ಹಲವರು ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆ ಬಹಳ ನೋವು ತರುತ್ತದೆ ಎನ್ನುವ ಕಾರಣದಿಂದ ಮತ್ತೊಂದು ಡೋಸು ತೆಗೆದುಕೊಳ್ಳಲು ಹಿಂಜರಿಯುತ್ತಾರೆ ಎನ್ನುತ್ತಾರೆ ಭಾರತದ ಸಮಗ್ರ ಆರೋಗ್ಯ ಸರ್ವೇಕ್ಷಣಾ ಯೋಜನೆಯಲ್ಲಿ ಮಹಾರಾಷ್ಟ್ರ ರಾಜ್ಯದ ಸರ್ವೇಕ್ಷಣಾ ಅಧಿಕಾರಿ ಪ್ರದೀಪ್‌ ಆವಟೆ. “ಒಂದು ಡೋಸು ಲಸಿಕೆ ಪಡೆದ ಜನ ಇನ್ನೊಮ್ಮೆ ಪಡೆಯಲು ಇಷ್ಟ ಪಡುವುದಿಲ್ಲ.” ಎಂದು ಆತ ಹೇಳಿದರು. ಈ ಹಿನ್ನೆಲೆಯಲ್ಲಿ ಮಹಾರಾಷ್ಟ್ರ ಸರಕಾರವು ಪ್ರಕಟಿಸಿರುವ ಮಾಹಿತಿಯು ಲಸಿಕೆ ಕಡಿಮೆ ಪರಿಣಾಮಕಾರಿ ಎಂದು ತಿಳಿಸಿತ್ತು. ಇವೆಲ್ಲವೂ ಒಟ್ಟುಗೂಡಿ ಮಹಾರಾಷ್ಟ್ರ ಸರಕಾರವು ಲಸಿಕೆ ನೀಡುವುದನ್ನು 2019ರಿಂದ ಮುಂದುವರೆಸದಂತೆ ಮಾಡಿತು.

ಲಸಿಕೆಯ ಪರಿಣಾಮ ಕಡಿಮೆ ಆಗುವುದಕ್ಕೂ ಅದರ ಸಾಮರ್ಥ್ಯದ ಪರೀಕ್ಷೆ ವಿಫಲವಾಗುವುದಕ್ಕೂ ಯಾರೂ ತಳುಕು ಹಾಕಲಿಲ್ಲ. ಬಹುಶಃ ಸಾಮರ್ಥ್ಯದ ಪರೀಕ್ಷೆಯ ವಿವರಗಳು ಸಾರ್ವಜನಿಕವಲ್ಲವಾದ್ದರಿಂದ ಇರಬಹುದು. ಮುರ್ರೇಕರರಿಗಂತೂ ಲಸಿಕೆ ಹೀಗೆ ಪರಿಣಾಮ ಕಳೆದುಕೊಳ್ಳುತ್ತಿರುವುದು ಒಂದು ವಿಸ್ಮಯವೇ ಆಗಿತ್ತು. ಏಕೆಂದರೆ ಅದು ದಂಡವತೆಯವರ ಶೋಧಗಳಿಗೆ ತದ್ವಿರುದ್ಧವಾಗಿತ್ತು. ಆದರೆ ಅವರಿಗೆ ಸಮಯದಲ್ಲಿ ಅರ್ಥವಾಗಿದ್ದು ಇಷ್ಟೆ. ದಂಡವತೆಯವರು 1994ರಲ್ಲಿ ನಡೆಸಿದ ಅಧ್ಯಯನಗಳು ಹಾಗೂ ತಮ್ಮ ಅಧ್ಯಯನಗಳ ನಡುವಿನ ಅವಧಿಯಲ್ಲಿ “ಏನೋ ಮಹಾನ್‌ ವ್ಯತ್ಯಾಸ ಆಗಿತ್ತು.”

ಲಸಿಕೆಯ ಬಳಕೆಯನ್ನು ಸ್ಥಗಿತಗೊಳಿಸಿದ ಎನ್‌ಐವಿ.

ಲಸಿಕೆಯ ಬಗ್ಗೆ ಅನುಮಾನಗಳು ಬಲವಾದಂತೆ, ಎನ್‌ಐವಿಯು ತಾನೇ ಲಸಿಕೆಯ ಬಳಕೆ ಪ್ರಯೋಜನಕಾರಿಯಲ್ಲವೆಂದು ತೀರ್ಮಾನಿಸಿತು. ಎನ್‌ಐವಿಯು ಹಲವಾರು ವರ್ಷಗಳ ವರೆಗೆ ಕೆಏಫ್‌ಡಿ ವೈರಸ್ಸನ್ನು ತನ್ನಲ್ಲಿದ್ದ ಅತ್ಯಂತ ಕಟ್ಟು ಸುರಕ್ಷತೆಯ ಪ್ರಯೋಗಾಲಯದಲ್ಲಿ ಅಧ್ಯಯನ ಮಾಡಿತ್ತು. ಆಕಸ್ಮಿಕವಾಗಿ ಆಗಬಹುದಾದ ಸೋಂಕಿನಿಂದ ರಕ್ಷಿಸಲೆಂದು ಅದು ತನ್ನ ಸಿಬ್ಬಂದಿಗಳಿಗೆ ಐಎಎಚ್‌ವಿಬಿಯ ಉತ್ಪನ್ನವನ್ನು ನೀಡುತ್ತಿತ್ತು.

2018ನೇ ಇಸವಿಗೆ ಸ್ವಲ್ಪ ಮೊದಲೇ ಎನ್‌ಐವಿಯು ಲಸಿಕೆ ನೀಡಿದ ಮೇಲೆ ಅಥವಾ ವೈರಸ್‌ ಸೋಂಕಿದ ನಂತರ ದೇಹದಲ್ಲಿ ರೂಪುಗೊಳ್ಳುವ ಎರಡು ಬಗೆಯ ಆಂಟಿಬಾಡಿ (ಪ್ರತಿಕಾಯ)ಗಳನ್ನು ಪತ್ತೆ ಮಾಡಲು ಪರೀಕ್ಷೆಗಳನ್ನು ಸಿದ್ಧಪಡಿಸಿತ್ತು. ಸಂಸ್ಥೆಯು ಲಸಿಕೆ ಪಡೆದ ತನ್ನ ಸಿಬ್ಬಂದಿಗಳಲ್ಲಿ ಈ ಪ್ರತಿಕಾಯಗಳಿವೆಯೇ ಎಂದು ಪರೀಕ್ಷಿಸಿತು. “ನಮಗೆ ಒಳ್ಳೆಯ ಪ್ರತಿಕಾಯದ ಪ್ರತಿಕ್ರಿಯೆ ಕಾಣಲಿಲ್ಲ. ಲಸಿಕೆ ಕೆಲಸ ಮಾಡುತ್ತಿರಲಿಲ್ಲ,” ಎಂದು ಎನ್‌ಐವಿಯಲ್ಲಿ ಹಿರಿಯ ವೈರಸ್‌ ವಿಜ್ಞಾನಿ ಆಗಿರುವ ಪ್ರಜ್ಞಾ ಯಾದವ್‌ ಮಿಂಟ್‌ ಗೆ ತಿಳಿಸಿದ್ದಾರೆ. 2019ನೇ ಇಸವಿಯಲ್ಲಿ ಮೌರ್ಯ ಅವರು ನಿವೃತ್ತಿಯಾದ ಬಳಿಕ ಕರ್ನಾಟಕ ಆರೋಗ್ಯ ಇಲಾಖೆಯು ಪ್ರಜ್ಞಾ ಯಾದವರ ಬಳಿಯೇ ಸಲಹೆ ಪಡೆಯುತ್ತಿದೆ.

ಯಾದವರ ಕಥೆಯೂ ಸ್ವಾರಸ್ಯಕರವೇ. ಭಾರತದ ಪ್ರಖ್ಯಾತ ಕೋವಿಡ್‌ ಲಸಿಕೆ, ಕೋವ್ಯಾಕ್ಸಿನ್‌ ತಯಾರಿಕೆಯಲ್ಲಿ ಬಳಸಿದ ಸಾರ್ಸ್‌ ಕೋವಿ-2 ವೈರಸ್ಸಿನ ತಳಿಯನ್ನು ಪ್ರತ್ಯೇಕಿಸಿದ್ದು ಕೂಡ ಅವರ ಕೆಲಸವೇ. 2018ರಲ್ಲಿ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ಕ್ಷೀಣ ಪ್ರತಿಕ್ರಿಯೆಯಿಂದಾಗಿ ಎನ್‌ಐವಿಯು ಲಸಿಕೆಯ ಬಳಕೆಯನ್ನೇ ನಿಲ್ಲಿಸಿಬಿಟ್ಟಿತು ಎಂದು ಅವರು ಮಿಂಟ್‌ ಗೆ ತಿಳಿಸಿದರು.

ಆದರೆ ಯಾದವ್‌ ಅವರ ತಂಡ ತಮ್ಮ ಈ ಫಲಿತಾಂಶಗಳನ್ನು ಪ್ರಕಟಿಸಲಿಲ್ಲ. ಜೊತೆಗೆ ಆಕೆಯೂ ವಿಡಿಎಲ್‌ ಹಾಗೂ ಐಎಎಚ್‌ವಿಬಿ ಲಸಿಕೆ ತಯಾರಿಕೆ ಮುಂದುವರೆಸಿದ್ದನ್ನು ಬೆಂಬಲಿಸಿದ್ದರು. ಉದಾಹರಣೆಗೆ, ಆಕೆ ಲಸಿಕೆಯನ್ನು ಬಿಡುಗಡೆ ಮಾಡುವ ಮುನ್ನ ಅಗತ್ಯವೆನ್ನಿಸಿದ “ಸುರಕ್ಷತಾ ಪರೀಕ್ಷೆ” ಎಂಬ ಪರೀಕ್ಷೆಯನ್ನು ಮಾಡಲು ವಿಡಿಎಲ್‌ಗೆ ಸಹಾಯ ಮಾಡುತ್ತಿದ್ದರೆನ್ನುವುದಕ್ಕೆ ಮಿಂಟ್‌ ಗೆ ಪುರಾವೆ ದೊರಕಿದೆ.

ಈ ಹಿನ್ನೆಲೆಯಲ್ಲಿಯೇ ಡಿಸೆಂಬರ್‌ 2021ರಲ್ಲಿ ಕೆಎಫ್‌ಡಿ ಲಸಿಕೆಯ ಇನ್ನೊಂದು ತಂಡವು ಸಾಮರ್ಥ್ಯ ಪರೀಕ್ಷೆಯಲ್ಲಿ ವಿಫಲವಾಯಿತು. ಈ ಸಂದರ್ಭದಲ್ಲಿಯೂ ಲಸಿಕೆಯ ಸಾಮರ್ಥ್ಯ ಕುಂದುವುದಕ್ಕೆ ಕಾರಣ ಎನ್ನಲಾದ ಕ್ರಮವನ್ನೇ, ಅಂದರೆ ಹಲವಾರು ಬಾರಿ ಸಂಖ್ಯಾಭಿವೃದ್ಧಿ ಮಾಡಿದ ವೈರಸ್‌ ಅನ್ನೇ ಲಸಿಕೆ ತಯಾರಿಕೆಯಲ್ಲಿ ಐಎಎಚ್‌ವಿಬಿ ಬಳಸುತ್ತಿತ್ತು ಎಂದು ಮಿಂಟ್‌ಗೆ ದೊರಕಿರುವ ದಾಖಲೆಗಳು ತಿಳಿಸುತ್ತವೆ. ಅಂದರೆ, ಎನ್‌ಐವಿಯಿಂದ ಸಂಸ್ಥೆಗೆ ಹೊಸ ವೈರಸ್ಸುಗಳ ಮಾದರಿ ದೊರಕಿರಲೇ ಇಲ್ಲ.

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What do CDSCO officials do during vaccine-manufacturing site inspections?

This post is born out of sheer frustration. I don’t hope to achieve anything by writing this post. After all, everyone already knows what a hopelessly opaque organisation CDSCO is. This has been documented many times over, but CDSCO doesn’t care. What I do hope to document, however, is just the sheer, enthralling mystery of it all.

On 2 April 2022, Indians heard the news that the WHO had suspended all purchases of Covaxin from Bharat Biotech, after having found what were obviously major deviations in Good Manufacturing Practices. They also learnt that Bharat Biotech had helpfully offered to suspend all exports of Covaxin, because it was the right thing to do. However, the company seemingly didn’t think it was necessary to suspend production and sales of Covaxin in India.

This news bothered, but didn’t surprise industry insiders. It’s fairly well known that CDSCO imposes more lenient quality and manufacturing standards on Indian companies than ICH regulators do. And WHO tends to impose ICH standards on most medicinal products too. So, what seemed like a major violation to WHO perhaps didn’t mean anything to the Indian regulator.

But having followed the Bharat-Biotech-Covaxin saga for so long, and being the object of a defamation lawsuit by the company to boot, I was naturally curious. In April 2021, I had written in detail about Brazil’s ANVISA, a regulator who follows ICH standards, finding serious GMP violations in Bharat Biotech’s Covaxin manufacturing process. This led to Brazil cancelling its procurement order of Covaxin altogether. Even then, Bharat Biotech had brushed off the issue, saying that Brazil was politicising things. And CDSCO hadn’t said a word.

Now, here was the WHO making the same claim, that Bharat Biotech had violated GMP while making Covaxin. Was WHO also playing politics? I was inclined to believe it was not. And that Bharat Biotech had indeed screwed up. This got me wondering: what was it about the GMP violations that WHO considered to be serious enough to suspend vaccine purchases, but CDSCO considered to be a non-issue? I was seized with an itch to understand these violations in granular detail. But the WHO had published no inspection report on its website (the WHO does publish inspection reports sometimes, but it isn’t very clear when it chooses to do so, and when it doesn’t).

However, thanks to responses from WHO’s media team when I wrote this story, I knew that WHO had asked CDSCO officials to accompany them to the fateful inspection of Bharat Biotech’s Telangana Covaxin manufacturing site between 14th-22nd March 2022. WHO’s team had also told me that they had subsequently held meetings with CDSCO, so that both agencies could “coordinate our actions”. And while the WHO is, unfortunately, not covered by India’s Right to Information Act, the CDSCO is.

So, I filed an RTI query with CDSCO, asking them for the WHO inspection report, which I assumed they had a copy of. My expectation was that CDSCO would deny my request under section 8(1)(e), claiming it has a fiduciary responsibility towards Bharat Biotech (Yes, they have been known to use this section to deny information about the corporations they regulate!). But the reply I got was not one I was prepared for. After the usual forwarding of the RTI query from one department to another, CDSCO said they didn’t have the inspection report at all!

Now, this was decidedly odd. By then, Bharat Biotech had received an Emergency Use License from the WHO; infact, the WHO inspection was a part the agency’s post-EUL diligence. And according to this document on the EUL procedure, the WHO enters information-sharing agreements with the national regulators of record, when it issues EULs. The idea of this agreement is that the national regulator will share all the data on quality/efficacy/safety that it has with WHO, so that WHO can make a determination about whether the vaccine is fit to receive an EUL.

It’s obvious that some form of information-sharing agreement does exist between the WHO and CDSCO. Prior to awarding the EUL to Covaxin, the WHO had not inspected Bharat Biotech’s manufacturing site, which it typically does during the pre-qualification process. Instead, this inspection had been waived off due to the pandemic. As an alternative, the WHO had relied on the report from the CDSCO’s inspection of Bharat Biotech’s Covaxin manufacturing site. Given this, we already know that CDSCO was freely sharing information with the WHO. Which begs the question: why would such an information-sharing agreement not cut both ways? After all, one of the objectives of the pre-qualification/EUL process is to build capacity of national regulators. And what better way for WHO to build CDSCO’s capacity than to share its inspection report with CDSCO?

So, why was CDSCO claiming it didn’t have the inspection report? I tried to resolve this conundrum by asking the WHO media cell again if the WHO shared the inspection report with Bharat Biotech. However, the WHO media team didn’t respond this time.

Confused, I decided to file a second RTI query with CDSCO. After all, even if the WHO didn’t give CDSCO a copy of its inspection report, surely there must be some written communication related to the joint inspection, since both agencies were supposed to “coordinate” actions. At the very least, CDSCO officials inspecting the manufacturing facility would have made some notes of their own? Typed up a report of some sort, and submitted it to their seniors? A reasonable assumption, one might think.

And so, in my second RTI query, I asked CDSCO for all written communication from the WHO to CDSCO, and all reports written by CDSCO. A month later, I got their response. Guess what? The vaunted apex drug regulator of India again claimed it had nothing!

Which brings me to the enthralling mystery I spoke about in paragraph 1. What *exactly* were CDSCO officials doing throughout the nine-day inspection they accompanied the WHO on? My imagination fails to come up with an answer. Were they just sauntering around, cleaning their teeth with toothpicks? Were they serving chai and sandwiches to WHO officials, as @grumpeoldman jokingly(?) suggested on Twitter? Is it that the WHO did give CDSCO a copy of their inspection report, and the CDSCO officials absent-mindedly wrapped the sandwiches in this report and gave it back? Did CDSCO officials doodle in their notebooks all the time? If so, why didn’t they do me the kindness of sending me their doodles in the RTI reply, as reward for my labours?

I really cannot think of any explanations. Somehow, I find it hard to believe that CDSCO officials would be foolish enough to lie in an RTI response. I am not saying it’s impossible, but how brazen that would be! And yet, the alternative explanation is equally scary to contemplate. Is this how CDSCO officials carry out inspections of manufacturing facilities?

Such an inspection is not just critical, but complex. Because vaccine manufacturing is complex. Such an inspection would require the full alertness of the CDSCO officials. And certainly, it requires them to take *some* notes. But, increasingly, it seems like CDSCO officials did nothing more than have a nine-day picnic at the manufacturing site.

PS: I asked the Drug Controller General of India, VG Somani, how it was possible, as the RTI reply claimed, that CDSCO officials had no record of the inspection. Feeling cheeky, I also asked if they did nothing more than have chai and samosa (/sandwich). I didn’t get a response. I also asked CDSCO’s Central Public Information Officer, B Sarala Devi, whose signature was on one of the RTI responses, for clarifications. I didn’t get a response from her either.

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India and the nitrosamine saga

In my recent article published in Mint (behind a metered paywall reset every month), I wrote about how India was dealing with the issue of nitrosamines – carcinogenic compounds that can contaminate drugs. Several wealthy countries, like the US, European Union countries, and Australia, are taking nitrosamine contamination very seriously. India, on the other hand, has been dragging its feet. Neither the central Indian drug regulator, CDSCO, nor state drug regulators, have undertaken nitrosamine testing; nor have they mandated that pharmaceutical firms keep nitrosamines within safe limits.

Soon after I wrote this article, I received feedback from several sources in a Clubhouse discussion and through other forums. I am summarising some of the feedback and questions raised here:

  1. When we talk about regulating nitrosamine impurities, we also need to talk about far more basic problems with the Indian drug supply

Nitrosamine impurities are a bit of a ‘cutting-edge’ problem, whereas the India regulator and the Indian Pharmacopoeia are yet to fix basic drug-quality problems like the enforcement of Good Manufacturing Practices or the use of up-to-date technologies to test for other, arguably more toxic, impurities.

Think of the diethylene glycol (DEG) poisoning that killed atleast 20 children in Jammu and Himachal Pradesh in 2020. DEG is a deadly chemical, which destroys the kidneys, and the children had consumed a cough syrup contaminated with it. DEG is an extremely well known pharmaceutical adulterant, there are suitable methods available to test for it, and Indian law has safeguards to prevent such poisoning. In other words, DEG is not like nitrosamines – it’s a far older story.

And yet, more than eighty years after the first recorded case of drug contamination with DEG in the USA, in which over 100 people died, India is still seeing children die from DEG-contaminated medicine. We already know that many very basic GMP failures occurred in the Jammu-Himachal-DEG case (look out for my article on this topic, coming soon). When we aren’t ensuring such basic quality checks yet (i.e pharma companies testing their raw materials for well-known toxins like DEG), can we really expect pharma companies to respond to the nitrosamine problem?

What’s more, nitrosamines are not the only area in which the CDSCO and the Indian Pharmacopoeia Commission (IPC) are lagging behind. The Indian Pharmacopoeia is frequently slow in keeping up with global scientific and regulatory changes, a pharma expert who runs an API/formulations firm told me. They cited the example of so-called elemental impurities. Elemental impurities, as the name suggests, are a range of elements that shouldn’t be present in medicines, because they are toxic and not of much therapeutic use. The most toxic among them are heavy metals like lead and arsenic, which can creep into medicines through mined excipients like talc and titanium dioxide.

Until very recently, most global pharmacopoeias used a now obsolete, 100+ year old test for these impurities. This test was neither particularly sensitive or specific – it couldn’t differentiate heavy metals from each other. To conduct it, a chemist must visually compare the colour of a solution containing the elemental impurity with the colour of a lead sulphide solution. If the colour of the test solution is lighter than the lead sulphide solution, it means total amount of heavy metals is within limits. One can imagine how crude this test would be; the expert told me that its results vary widely, depending on the lab lighting, glassware quality or even the eyesight of the person performing the test!

This is why the world is moving to better technologies and methods for elemental impurities. In a process that began almost a decade ago, and culminated in March 2019, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) adopted new guidelines for measuring them. These guidelines set far more stringent upper limits for 24 elemental impurities, including many that cannot be detected in the color test. The colour test cannot detect the low levels prescribed by ICH anyway; if a pharma company wants to adhere to these limits, it must adopt more modern methods such as Inductively Coupled Plasma – Mass Spectroscopy (ICP-MS). Moreover, the ICH-Q3D, as the ICH’s elemental impurity guidelines are called, recommend a risk-based approach to testing. Instead of testing every product for every element, whether nickel, cadmium or arsenic, a manufacturer is advised to follow a more sophisticated approach: they must first assess the risk that the impurity is present, and then device a testing strategy for it.

Soon after, and in some instances, before, the ICH-Q3D was adopted, ICH members, like Europe, Brazil, the US and Japan have adopted these guidelines and updated their pharmacopoeias. The US subsequently knocked out the 110-year old color test for heavy metals. But India, as usual, is lagging behind. It continues to use the outdated color test, which also makes life hard for manufacturers who supply to US or Europe. Even though they may have conducted risk assessments for their medicines, and tested the medicines using ICP-MS, they still have to perform the obsolete color test to satisfy Indian regulators. “Liters of lead solutions used needlessly. Not good for the environment also,” the expert told me.

This is not the only example. There are many more monographs in the Indian Pharmacopoeia that have failed to keep up with global changes. Nitrosamines are just the latest in this line. More than one expert told me that given the costs and complexity of controlling for nitrosamines, the IPC and the drug regulator may drag their feet on bringing in new regulation, because many small Indian firms may not be able to keep up.

Still, there is some movement on the elemental-impurity front. The IPC website has published a general chapter on elemental impurities, along the lines of the ICH-Q3D, for comments from stakeholders. It’s hard to say if this general chapter will become official soon though, because complying with it would require small and medium manufacturers to conduct risk assessments, and perhaps invest in new infrastructure, like ICP-MS systems. All that is not necessarily easy.

2. How much will it cost Indian manufacturers to keep nitrosamine contamination in check?

When it comes to quality in the Indian market, the issue of cost is never far behind. If India adopts the FDA’s and EMA’s approach to nitrosamine contamination, all pharma companies will need to assess the risk that *any* of their products can potentially contain nitrosamines. This will, no doubt, cost small and medium firms a pretty penny. And India is a price sensitive market, with government programs like Jan Aushadhi trying to drive prices down further, without necessarily keeping an eye on quality.

Here is a look at why controlling for nitrosamines is neither easy, nor cheap for manufacturers. Consider a pharma firm, say ABC, which manufactures some 100 formulations and 50 APIs. For every formulation, this company will need to contact its API supplier and its excipient supplier, to understand the risk that these raw materials contain either nitrosamines, or the building blocks of nitrosamines (nitrites, amines etc). These building blocks could be present in the API or the excipient, or they could be impurities in the API or excipient.

Recall that this is how NDMA ended up in Zhejiang Huawei’s valsartan – a chemical (sodium nitrite) used to quench leftover sodium azide reacted with an impurity in the solvent dimethylformamide. In other words, NDMA was formed in a side reaction of the manufacturing process. To predict this kind side reaction, a manufacturer must have in-depth knowledge of their synthetic route, and every possible impurity that can arise from it. And I am told that many manufacturers, especially small firms who don’t invest in research, don’t have such knowledge.

Once manufacturer ABC completes its risk assessment and finds that one of its drugs has a high chance of being contaminated by, say, NDMA, they must test a few batches of the drug to show that the total NDMA levels are a small percentage of the limit allowed by regulators. If this testing reveals that NDMA is approaching the upper limit in multiple batches, ABC must start testing every batch of the final product, routinely.

To do this, it must invest in expensive apparatus – maybe a liquid chromatography-high resolution mass spectroscopy system (LC-HRMS), that costs upto Rs 2 crore. Then it must find a skilled professional to operate it, and that skilled professional must develop an appropriate method to test for NDMA in the drug. This is because a pharma company cannot directly copy publicly available testing methods: each drug and formulation requires a custom-test.

ABC must repeat this process for all of its 100 formulations and 50 APIs. As I reported in Mint, even large pharma companies like Sun Pharma and Zydus Cadila, are struggling with this challenge. How will small and medium firms deal with it?

Which brings us to the issue of price. Any pharma company that does all this, and invests in new skills and infrastructure to control nitrosamines, may want to raise prices. Will Indian consumers accept this increased cost? Will government schemes like Jan Aushadhi pay for it?

I think the answer to this question will determine whether Indians will ever get nitrosamine-free drugs.

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