On 8 July 2022, 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.
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. He is an expert and accomplished entrepreneur in pharmaceuticals, biomedical product development, drug regulation, and information technology. Mr Thakur, who blew the whistle
on the massive fraud practiced by the pharmaceutical giant Ranbaxy Laboratories, is an Executive Chairman at Medassure Global Compliance Corporation, an American consultancy and risk management company, and 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.
Mr 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: To start with Good Distribution Practices, currently there is no governing law that oversees what happens to medicine once it leaves the manufacturer’s facility, and how it makes it to the patient. For instance, injectables and vaccines have to be stored in cold conditions while they are in transit. Even for medicines like capsules and tablets that are light-sensitive and temperature-sensitive, we do not have a law at all.
This was an opportunity for the new law to address this and put regulations in place – that when medicines leave the manufacturer’s facility, and when it travels through the supply chain like the stockists, agents, and finally to the pharmacy, it has to be maintained properly. We have no law governing this process. It is a missed opportunity for distribution practices for the law to address this specific area.
As far as GMP is concerned, when we think about medicine quality, we refer to the end product. Although there is some perfunctory mention of GMP in the law, it is never actually implemented. It was another opportunity lost where the law could have made it a lot more rigorous for manufacturers to follow the manufacturing practices in the making of drugs.
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?
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?
The reason this happens is that the people that are running the DCGI are not qualified to look at the review process and understand how the evidence is actually evaluated. 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] Bioncon Biologics by waiving off responsibilities for a clinical study. The problem is that the people who are running the DCGI’s office are not qualified to look at evidence-based medicine.
In the past, Parliamentary Standing Committees have highlighted the fact that the person heading the DCGI is not qualified to run the national regulator. In 2012, the Parliamentary Standing Committee on Health and Family Welfare, in its report
on the functioning of the CDSCO, looked at the qualifications of the drug regulator and said that this is not the kind of person that should be running the regulator.
Since the pharmaceutical lobby essentially captures the drug regulator, nothing changes. It was a good opportunity for the Ministry to implement proper recommendations that came from the government itself.
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 be given to the manufacturer to explain why the product is actually not of standard quality. However, a lot of this is not made transparent. I have not seen a single inspection report by CDSCO. We need to make sure that whatever the CDSCO is doing – whether it is giving an opportunity to show cause if the drug fails 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 stock 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 the 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?
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. You have a prescription written up, you take the prescription and give it to the pharmacy. You then go to another pharmacy and get the same prescription filled. I think the fundamental issue is with the way we write prescriptions and the integrity of how the prescription is held.
We have made specific recommendations to fix the process. The prices are driven up among the pharmaceutical manufacturers, which needs to be addressed, and our online pharmacies will make a difference there. In order for online pharmacies to work, we need regulations governing manufacturing practices.
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 sterile and proper? Where is the regulation? Where is the law governing that?
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 the responsibility of the executive to make rules about it is delegated. If the parent statute is completely silent on it, how will the rules be made?
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: That is the most devious and underhanded provision of this Bill. In the current law, the punishments that are available for 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. For instance, Azithromycin, an antibiotic that was used extensively, although it did not do anything for COVID-19, is a good antibiotic for what it is intended. If Azithromycin is made by ‘A’ company and it says 100 milligrams, the rule says that even if it contains 70 milligrams, it is acceptable. How is that acceptable?
The rule then says that even though the manufacturer says 70 milligrams, the only thing that the law can do at that point is to find them and impose a monetary penalty. They are taking away the right of the court to actually imprison such people.
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: The problem that we have in the bill is not just limited to what is in the fourth schedule; it also 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. But 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 seen what the current structure did during the COVID-19 pandemic with all kinds of nonsense being approved. Even for Covaxin, the data 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.
The people who drafted this were from the CDSCO itself. 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.
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.
(Sarah Thanawala is a staff writer at The Leaflet)