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Home / Science / Health /  The many infirmities of drugs and medical devices bill

The new Drugs, Medical Devices and Cosmetics Bill 2022—proposed replacement for the pre-Independence Drugs and Cosmetics Act 1940—is a step forward in making the law more contemporary but still falls short of what is required.

Recognising medical devices as a separate category in its own right is welcome—till now, it has been regulated on par with drugs, vetted by the same technical body that vets drugs. Some experts have pointed to language in the medical devices section of the bill, such as adulteration, which suggests inadequate appreciation of medical devices. It is welcome that a separate technical committee would evaluate medical devices.

It is strange, however, that the bill ignores the increasing popularity of health apps on phones and the US Food and Drug Administration’s approval for several mobile phone apps as therapeutic means, including for diabetes control and cognitive behaviour therapy for those undergoing de-addiction. The bill should provide for regulation of health apps that people will download by the billion.

A related lacuna relates to use of health data. While the Data Protection Bill envisages protection of health data, that data regulator is not concerned with the use of mass health data for clinical purposes. It might seem onerous to place on the drugs regulator the responsibility to regulate use of health data as well. But someone has to do it. That strengthens the case for a revamp of the regulator apparatus to assemble the assorted, requisite expertise in the body, instead of treating it as a body to be staffed with babus on deputation.

The law will also bring online pharmacies into the ambit of regulation. India remains a country where any medicine is available from the friendly neighbourhood pharmacy without any prescription. At least some classes of drugs, especially pain relievers, sleeping pills, anti-depressants and the like must be sold only on the basis of valid prescriptions. Online pharmacies should not be an obstacle to enforcement of this norm.

The law also seeks to clean up provisions relating to clinical trials.

Following a Supreme Court directive a decade ago, the government modified the rules, in 2013, to the 1940 law, to mandate stiffer compensation for any damage sustained during drug trials, and also incorporated transparent provisions for obtaining compensation in the so-called Informed Consent Form that clinical research organisations are required to get trial participants to fill out. These are sought to be imported into the new law. This is welcome, as clinical trials in India represent an enormous opportunity that goes underutilised due to widespread misapprehension about the ethical standards followed by those who conduct such trials.

The World Medical Association first adopted its ethical principles for experiments involving human subjects in 1964 and has been updating these on a regular basis. Treatment and compensation for any damage suffered during medical trials has been a basic principle. It would help, if the law were to incorporate a provision to adopt the most current norms adopted by the World Medical Association.

With medical science standing on the threshold of significant advances in gene-based treatments, the law should incorporate not only drugs based on DNA and RNA, but also gene editing. Techniques such as CRISPR-CAS9 permit fairly precise editing of genes, opening the way for curing conditions previously thought untreatable. While the ethics of gene editing cannot be incorporated into any law, the legal framework must provide for resolving the specific ethical questions raised by genetic intervention of every kind.

The bill does not address a central problem with India’s control of drugs standards. This is scattered across the states and the Centre, with non-uniform standards and qualifications for personnel. This must change. The present situation, in which the Drugs Controller can be an officer from the police service or the revenue service must change. It is not enough to specify a medical degree as an eligibility criterion for being a regulator, either. The requisite experience in research and manufacturing must be brought together in the regulatory body, drawing on various streams of relevant expertise. Nor can drugs standards be left to differential standards and assessment norms in different states. This must be centralised and strictly enforced.

In order to make the regulation of drugs and medical devices a rigorous process, and insulated from influence peddling mediated through politicians and civil servants, the regulator must be made autonomous, as in the case of telecom and power, with an appellate body instituted alongside. Both the regulator and the appellate body must be made accountable to Parliament, via a standing committee.

The Drugs, Medical Devices and Cosmetics Bill 2022 could, thus, do with many useful changes to make it useful in the present and future-ready, to boot.

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