Thakur exposes the underhanded provisions of the new Drugs, Medical Devices and Cosmetics Bill, 2022, and questions the intention behind the drafting of the bill.
——-
On July 8, the Draft Drugs, Medical Devices and Cosmetics Bill, 2022 was released for public consultation by the Union Ministry of Health and Family Welfare. The Draft Bill is intended to replace the existing, pre-independence legislation of the Drugs and Cosmetics Act, 1940. It aims to address the import, manufacture, and sale of drugs and cosmetics to ensure their quality, safety, efficacy, and performance.
The Bill has attracted major criticism from the relevant stakeholders.
India has 37 agencies tasked with enforcing drug regulation across the country – one in each state and Union Territory. The Central Drugs Standard Control Organization (‘CDSCO’), which is under the control of the Union Ministry of Health and Family Welfare, is the central drug regulator, and is headed by the Drug Controller General of India (‘DCGI’). The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945 make provisions for the central and state drug regulators to ensure the implementation of the law.
Dinesh Thakur is a public health activist focused on improving health policy in the United States and in India. Thakur, who blew the whistle on the massive fraud practiced by the pharmaceutical giant Ranbaxy Laboratories, is the Founder and Director of Thakur Foundation, an independent funding organization that focuses on creating sustainable progress in the areas of public health and civil liberties.
Thakur spoke to The Leaflet on the major gaps in the draft Bill, and how drug regulatory needs in India have gone severely unaddressed in the new bill.
Edited excerpts from the interview:
Q: The mention of Good Manufacturing Practices (‘GMP’), provided by the World Health Organization, is absent in the Draft Bill. Further, as a critique of the Bill co-written by you last month points out, the ‘Good Distribution Practices’ code (to address the issues of drug degradation during transit) was rejected to be included in the Bill by the Health and Family Ministry’s Drugs Consultative Committee. Can you elaborate on how the implementation of such a code, in addition to a legal structure, is instrumental?
A: The current draft has no mention of Good Distribution Practices. In fact, there is no governing law that provides oversight for the process when medicine leaves the manufacturer’s facility and eventually makes it to the patient. Many medicines, including injectibles, vaccines require to be stored at specific conditions throughout their life-cycle. Even tablets and capsules which are light and temperature sensitive need careful handling. This was an opportunity for the law to address this gap in our regulation; sadly, it does not do that.
Also read: Explained: How do Vaccines Work?
As far as GMP is concerned, when we think about medicine quality, we refer to the end product and not the way it is manufactured in our law. Although there is some perfunctory mention of GMP in the law, it is never actually implemented the way it ought to be. This was another opportunity lost where the law could have made it a lot more rigorous for manufacturers to follow the standards for drug manufacturing globally; sadly it does not do that.
Q: The Bill authorizes state governments and the Union Government to prescribe qualifications for their respective drug control officers. Can you explain if and how this is a problematic provision?
A: Think about what happened during the COVID-19 pandemic. The DCGI approved many drugs that were never a part of the National Treatment Plan. Although the drug controller approved certain medicines, the National Taskforce did not think it appropriate for such approved medicines to be included in the National Taskforce Guidelines. The question is why? Did the taskforce not think it appropriate for such medicines to be used for the treatment of COVID-19?
One of the reasons this happens is that the people that are running the drug controller’s office are either not qualified to evaluate the evidence they should or subvert the process by which such drugs are approved. Why did the Central Bureau of Investigation investigate S. Eswara Reddy, who was the former Deputy Drug Controller? He was trying to benefit [biotech company] Biocon Biologics by waiving off responsibilities for conducting a clinical study. One of the problems we have in our law is that vague statutes vest an inordinate amount of power with these unelected bureaucrats who pervert the process for ulterior motives. This was a great opportunity to fix such loopholes and make the law a lot more prescriptive and stringent. The proposed amendment does no such thing.
In the past, the Parliamentary Standing Committee on Health in its 59th Report has highlighted the fact that the person heading the DCGI is not qualified to run the national regulator. In its report on the functioning of the CDSCO, the Standing Committee made very specific recommendations on the qualifications of what makes a good DCGI.
Since the pharmaceutical lobby essentially captures the drug regulator, nothing changes. It has been ten years now since that report. This was again a good opportunity for the Ministry to implement proper recommendations that came from the government itself, but it doesn’t do so.
Q: The Draft Bill introduces ‘improvement notices’ (Section 67 of the Draft Bill) to enable the licensee to rectify any violations before instituting proceedings. What is your opinion on such measures aiming at better compliance with the law?
A: This is a good idea and the benefit of the doubt should always be given to the manufacturer to explain why their product is not of standard quality. However, a lot of this is not made transparent. I have not seen a single inspection report by CDSCO of any manufacturing facility made publicly available. We need to make sure that whatever the CDSCO is doing – whether it is giving an opportunity to show cause if the drug fails specifications or anything else – it has to be public.
When the United States Food and Drug Administration conducts an inspection, it publishes an inspection report. Why doesn’t our regulator tell the people of India what they found during the inspection? Why does the inspection report stay a secret? Why are they not published? Why are the stop production orders a secret? I don’t think there is anything wrong in asking the manufacturer to do a root cause analysis and explain why their product does not need quality standards. The problem is that it is all done behind everybody’s back. Why are the inspections not done in a transparent manner?
Therefore, these provisions, while an improvement, need to be implemented in a transparent and accountable manner in order to inspire trust within the Drug Regulator’s office.
Q: The draft Bill has mandated licence requirements for the sale of drugs through online mode (Sections 41 and 102 of the bill) and has authorised the Union Government to make rules to regulate it (Sections 83, 118 and 158 of the bill). How far can such licensing go in regulating online pharmacies?
A: The problem is not with online pharmacies but with the use of prescriptions. As a patient, you have a prescription written up, you take the prescription and give it to the pharmacy to be filled. You then go to another pharmacy and get the same prescription filled. This clearly is an abuse of the process. I think the fundamental issue is with the way we write prescriptions and the integrity of how the prescription is filled.
We have made specific recommendations to fix the process in our comments to the Ministry. Online pharmacies will help with price transparency, which is a subject that is often discussed. There is anecdotal evidence of cartelization among pharmaceutical companies which affects all of us. Online pharmacies have the potential to make this a lot more transparent and responsive to patients. But as everything else, we need proper regulations governing the function of these online pharmacies.
Imagine what we see with food delivery services such as Zomato and Swiggy right now – they are trying to deliver you food with backpacks behind their backs in rain, with 40-45 degree Celsius weather outside. Do you think the injectables will remain effective and proper when subjected to such extreme conditions? Where is the regulation? Where is the law governing this process?
There is no question about authorizing the government to make rules on regulating online pharmacies when the law itself is entirely silent on it. Rules can be made when the statute actually says that a particular issue is governed by it, and then it is the responsibility of the executive to make rules about it. If the parent statute is completely silent on it, how will the rules be made? By whom?
Q: Can you elaborate on how the provision that prescribes the lower punishment, under Section 56(e) of the Bill, for manufacturers where the drugs are declared NSQ (not of standard quality), is flawed?
A: This is the most devious and underhanded provision of this proposed Bill. In the current law, the punishments that are available for manufacturers of NSQ medicines have been diluted significantly in this new Bill. What the new bill is saying is there is actually a list of things that are acceptable and these are arbitrary and at the discretion of the drug inspector. For instance, take Azithromycin, an antibiotic that was used extensively although it did not do anything for COVID-19. It is a good antibiotic for what it is intended. If Azithromycin is made by ‘A’ company and it says 100 milligrams on the label, the rule says that even if it contains 70 milligrams, it is acceptable. If the new law goes into effect, the maker of such substandard products will not be criminally prosecuted anymore.
The only remedy available in the new law is to impose a monetary penalty. They are taking away the right of the court to actually imprison manufacturers who make substandard drugs.
Q: Can you explain the consequential impact of Section 71 of the Bill that allows ‘compounding’ of certain specific offences by the prosecuting drug controller, including the fourth schedule?
A: As I said, compounding basically ties the hands of the inspector and limits penalties to a paltry monetary fine. The bigger problem is that in the bill, it is not just limited to what is in the fourth schedule; it gives the government the ability to add more defects in the fourth schedule (Section 58 of the Draft Bill). What is listed in the fourth schedule is already scandalous. You can imagine what the industry will do, it will use its influence to keep adding to the current list of violations listed in this schedule. The net effect is that they can decriminalise a whole bunch of other things that are not even listed in the schedule at this point.
Q: With a long pending legal structure to regulate the pharmaceutical industry seeing another disappointment in the draft Bill, moving forward, what steps should be taken? What will it take to bring the shift in the drug regulatory system, that is, from serving the pharmaceutical industry to actually tending to public health?
A: We have all seen what the current structure did during the COVID-19 pandemic with the kind of nonsense being approved for treatment. Even for Covexin, the information of the members who approved it was not made publicly available. Nothing in this bill addresses transparency and accountability – it is the same kind of content that they keep bringing up time and time again with the draft Bills.
Also read: How Safe is Covaxin when Phase 3 Clinical Trial is Not Over?
The people who drafted this were from the CDSCO itself. This is clear conflict of interest. What incentive is it for them to actually change anything? If this government was serious about making things right, it would chuck this bill, and form an external committee with people other than those who wrote this bill.
For example, with AYUSH [Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy] medicines, the current bill decriminalises heavy metals (arsenic) in such medicines. The point is: who has written this bill and for whose benefit? Certainly not for the people of India.
(An earlier version of the interview uploaded this morning had some factual errors, which have been subsequently corrected online -Editor)
