A petition proposing a new roadmap for India’s new drug regulatory law

We recently sent a petition to the Ministry of Health & Family Welfare with regard to the ongoing process to draft a new Drugs, Cosmetics and Medical Devices Act. It is not clear whether the committee setup to draft this new law is even conducting public consultations. In our petition we made specific recommendations for a new law on drug regulation to replace the archaic Drugs & Cosmetics Act, 1940. We underscored the major concerns that need to be addressed and why it is imperative to do so.

We state in our petition that one of the foremost objectives of the new law should be to ensure transparency in the workings of the regulator. The current drug regulatory regime is opaque with little to no publicly available information about the basis of new drug approvals, the results of inspections of manufacturing facilities, recalls or prosecutions of manufacturers for failing to meet quality standards. It is imperative to ensure transparency in this regard for three reasons. First, the Right to Information is a fundamental right that requires public authorities to disclose information to citizens. Second, for the doctors to make informed decisions regarding the prescriptions for new drugs it is important for them to know the scientific basis of new drug approvals. Third, there is no single database, of inspections and quality test reports, publicly accessible to common citizens and procurement agencies to verify the quality record of pharmaceutical companies. Due to this unavailability, agencies often conduct their own inspections and testing that leads to wastage of public money and causes delays in the procurement process.

A second important issue we tackle in our petition is regarding the distribution of regulatory powers between the central and state governments. This current distribution of power is complex and leads to administrative complications.  As we state in the petition, it is advantageous to have one central regulator for four reasons. First, the central licensing authority will end the race among states to lower regulatory standards in order to attract investments from the pharmaceutical industry. Second, this step would be in consonance with the federal scheme of the Constitution because inter-state commerce as well as fixing standards for inter-state commerce is on the Union List in Schedule VII to the Constitution. Third, such centralization would promote co-ordination and information sharing with different drug inspectors across the country thereby improving efficiency. Fourth, it would make it easier for public to demand accountability and end the current ‘blame game’ between the centre and states regarding the accountability for poor quality of drugs in India.

A third issue we discuss in the petition is the issue of giving statutory status to the CDSCO along with a sustained source of financing. Such a statutory status would afford the regulator more flexibility with regard to recruitments and daily operations.  Furthermore, we underscore the need for building the capacity of the new statutory regulator with well-paid and well-qualified staff.  In particular we tackle the issue of qualifications for personnel. Most developed countries employ specialised doctors in leadership roles, while in India the CDSCO has been headed mostly by pharmacology degree holders. We recommend that the new regulator should be filled with individuals having specialised qualifications in medicine and public health.

A fourth issue we tackle is the urgent need to create a scientifically rigorous mechanism for approving “new drugs”. The Parliamentary Standing Committee raised concerns about the CDSCO approving the sale of new drugs  that were not approved in more lucrative jurisdictions like the U.S. and E.U. which follow higher regulatory standards. An inquiry revealed that the major problem with the entire process was the absolute discretion enjoyed by the DCGI in approving/rejecting applications. Consequently, subject expert committees (SECs) were created to advise the DCGI on new drug approvals but even this process failed to create a scientifically rigorous process that was transparent. These SECs release small summaries of their discussions that provide little detail on the nature of deliberations within the committee. Contrastingly, the American and European regulators release their internal ‘scientific reviews’ and ‘impact assessments’ for every new drug and this is the standard of transparency that should be aimed at  while creating any regulatory model.

A fifth issue we tackle is the need to revamp the regulatory framework for clinical trials. Various reports have shown the failure of Clinical Research Organisations (CROs) and hospitals to comply with basic medical ethics. Foreign regulators have also questioned data integrity at Indian CROs due to data fudging. Further, there is a sheer lack of scientific rigour is designing clinical trials. We therefore recommend ensuring complete transparency in the conduct of clinical trials that entails maintaining accurate registration data on the CTRI and publishing clinical trials data.

A sixth issue that we emphasize in our petition is the need to shift the regulatory focus from selling of drugs to the process by which such drugs are manufactured. The process of purchasing and sampling the drugs to be tested by analysts is arbitrary, and the budget allocation for the same is insufficient. This arbitrary process implies that only a small number of manufacturers and only certain drugs  are caught in the dragnet. Focusing on manufacturing process at each and every plant will lead to better outcomes. We recommend surprise inspections of manufacturing facilities and ensuring that people involved in manufacturing processes possess the requisite skills.

 A seventh issue we cover in our petition is the need to rethink criminal penalties as the standard tool of regulation. There has been a reluctance to use criminal prosecution as a tool by regulators, in cases of sub-standard drugs. They prefer imposing minor administrative penalties in such cases. The efficacy and adequacy of such punishments is questionable. Therefore, we recommend that the new law should provide regulators with an option to choose between existing imprisonment or a new system of monetary fines depending on the facts of the case and the degree of negligence or fraud involved. There should also be well-defined thresholds for criminal prosecutions.

The eighth issue we touch upon in our petition is the need to make it an offence to advertise or claim therapeutic uses of a drug without prior permission from the regulator. As of today, the statutory prohibition exists only against those advertisements which are obscene or targeted at specified list of diseases for which there is no known cure. This leaves out a wide range of potential advertisements that can make unsubstantiated claims. While rules for such prohibition have been enacted in the context of AYUSH drugs, we recommend enacting similar measures for all drugs. Lastly, we recommend overhauling the Indian Pharmacopeia Commission (IPC). The IPC publishes the Indian Pharmacopeia which contains monographs of various formulations and also sells reference standards to both industries and government laboratories. Anecdotal evidence suggests that the IPC is not very efficient in ensuring timely delivery of reference standards. These delays can cause further delays in manufacturing and testing by labs leading to inefficiencies. There are also concerns that the monographs are not updated in a timely manner, even for crucial drugs. Such delays can have adverse implications for public health in the long run. Therefore, we strongly recommend that government should consider revamping the IPC and review its functioning.

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