Takshashila Policy Advisory - Comments on the Draft Drugs, Medical Devices And Cosmetics Bill, 2022
Executive Summary
The Draft Drugs, Medical Devices And Cosmetics Bill, 2022 aims to replace the older Drug and Cosmetics Act, 1940 to reflect advancements in science and technology. This is a welcome development, since the drug manufacturing and distribution sector has evolved significantly in the past few decades. While the Bill recognises the need for changes, there are gaps which need to be filled to make the Bill more comprehensive.
Our major recommendations are:
Instead of the government building up capacity in state infrastructure for testing, the testing could be outsourced to the private sector.
The Bill should include and regulate supplements of various categories. These should be brought out from the ambit of Food Safety and Standards Authority of India regulation into the scope of this Bill.
The Bill should treat drugs from Ayurveda, Siddha, Sowa Rigpa, Unani And Homoeopathic Drugs with the same scrutiny as applied for modern medicine drugs. A 10 year period can be given to the manufactures to comply with this.
The Bill should have provisions which mandate post market adverse effect surveillance with a mechanism for complaints by the general public.
The Bill should mandate that Good Manufacturing Practices and Good Distribution Practices should be followed by manufacturers, traders and sellers.
The Bill should strengthen punishments for poor quality drugs.
Our Comments
Introduction
The Union Government has proposed to replace the old Drug and Cosmetic Act of 1940. We welcome the Government’s effort to update the Act to keep pace with the developments in the drugs, cosmetic and medical devices sector. In the recent past, serious cases of quality control have been noted in India. Further, the COVID-19 pandemic provided an opportunity for sharing information about drugs and vaccines and expediting their roadmap to patients. There is considerable interest in how regulation, particularly pertaining to intellectual property, can aid in the spread of knowledge and increase in access to drugs and other supplies.
It is therefore promising that the government seeks to update the 1940 Act, at a time that India can emphasise its commitment to drug quality control and expand its position as one of the major pharmaceutical providers in the world.
In this regard, the Bill should cover all aspects of drug quality - from production till its sale to the final customer. It should also recognise newer methods of formulating drugs/vaccines and distributing them. While the Bill does prescribe regulations to be drawn for online pharmacies, the Bill does require strengthening in other areas to become comprehensive. We have listed our recommendations for this strengthening below.
A. Focus on In-house Testing
Position under the Policy
Chapter II “TECHNICAL ADVISORY BOARDS, DRUGS LABORATORIES, MEDICAL DEVICES TESTING CENTRES AND CONSULTATIVE COMMITTEE”
Section 10 “Central Drugs Laboratory, Central Medical Devices Testing Centre and State drugs laboratories and State medical devices testing centres.”
The section calls for setting up and using existing Government testing centres and laboratories for approval and testing of drugs, devices and cosmetics.
Our comments
There is a paucity of testing capacity for quality control of drugs in India,. According to the last data available(2015)4, all central and state labs combined could only do around 1 lakh tests per year. There is a need to increase both the types of tests being performed and the quantity of samples being analysed. Therefore, a significant increase in testing capacity is necessary.
However, we recommend that instead of the government ramping up testing infrastructure, it can subcontract testing of existing and new drugs to private sector testing facilities. This would enable the government to ramp up testing quickly, save on building new infrastructure and utilise existing facilities.
B. Inclusion of Supplements into the Act
Position under the Policy
CHAPTER IV “MANUFACTURE, SALE AND DISTRIBUTION OF DRUGS AND COSMETICS AND CLINICAL TRIAL OF DRUGS”
The chapter doesn’t include supplements, which are instead governed by Food Safety and Standards Authority of India regulations.
Our Comments
The policy should explicitly mention and include supplements. The following should be excluded from the draft Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations, 2022 and be included in this act.
Food for Special Medical Purpose
These categories of supplements are to be taken under medical supervision. These should be subject to the same standard of efficacy and safety that drugs have to uphold.
We recommend that we the following categories can be included
Food for special dietary use
Health supplement
These categories of supplements claim to have certain health effects and benefits. If a substance claims to have an effect on your health, it should adhere to higher standards.
C. Special Status to Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy Drugs
Position under the Policy
A separate Chapter V “PROVISIONS RELATING TO AYURVEDA, SIDDHA, SOWA RIGPA, UNANI AND HOMOEOPATHIC DRUGS'' has been included which exclusively deals with drugs from above traditional medicine systems. Ayurveda, Siddha, Sowa Rigpa, Unani and Homoeopathic drugs are not covered under provisions from any other chapter. They have relatively relaxed quality regulation and control.
Section 86
(a) “Ayurveda, Siddha, Sowa Rigpa or Unani or drug” includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha, Sowa Rigpa and Unani Tibb systems of medicine, specified in the Fifth Schedule ” This means that the drugs don’t need to undergo safety and efficacy trials which modern medicine drugs are subjected to.
(m) “ “Homoeopathy drug” includes any Homeopathic Medicine or a drug which is recorded in Homoeopathy provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative literature of Homoeopathy, as may be specified from time to time by the Central Government by notification in the Fifth Schedule; and which is prepared according to the techniques of the Homoeopathy Pharmacopoeia of India”
(q) ““Pharmacopoeia” in relation to Ayurveda, Siddha, Sowa-Rigpa, Unani and Homeopathy drugs means the Ayurveda or Unani or Sowa-Rigpa, Siddha or Homoeopathy Pharmacopoeia of India published by the Pharmacopoeia Commission of Indian Medicine and Homeopathy”
The “Fifth Schedule” specifies the arbitrary cutoff date of 1964, before which authoritative texts published would be considered.
Our comments
The Policy guidelines should bring all drugs into the same standards of safety and efficacy:
A 10 year period given to manufacturers of existing traditional medicine drugs to comply with safety and efficacy standards.
All new traditional medicine drugs too undergo safety and efficacy trials before being allowed commercially.
The Policy could also advocate for more resource allocation into traditional medicine.
D. Post Market Surveillance/Adverse Effects Monitoring
Position under the Policy
The draft doesn’t include any provisions which mandate or regulate surveillance post the release of the drug in the market
Our comments
The Policy must define and mandate post market surveillance by the manufacturer. We suggest a similar mechanism to the one existing in the UK( https://yellowcard.mhra.gov.uk/). A mechanism in which both the general public and medical practitioners can file reports of adverse effects or false claims of drugs, cosmetics or medical devices.
E. Good Manufacturing Practices and Good Distribution Practices
Position under the Policy
Good Manufacturing Practices and Good Distribution Practices should be followed by manufacturers, traders and sellers.
Our Comments
Though GMP is covered in Schedule M of the Drugs and Cosmetics Rules, 1945, the Bill should explicitly call for compliance with GMP and Good Distribution Practices. Penalties for non-compliance should also be specified.
F. Punishments for Poor Quality Drugs
Our Comments
There is a case to revisit and strengthen punishments for poor quality drugs - be it spurious or adulterated. Criminalising these incidents will be a strong deterrent to any practices that can accidentally result in poor quality drugs. Thus, section 56(e) needs to be revisited and reduced punishments need to be reviewed. Further, the Bill provides for the government to notify which defects can be included in the fourth schedule and thus fall under the ambit of section 56(e). Changes to the schedule should be under Parliamentary review, not the government. Thus this clause should be removed.
Authors
