Drugs, medical devices & cosmetics bill 2022: A law whose date has passed

Earlier this month, the Department of Health unveiled a new bill to replace the Medicines and Cosmetics Act 1940. The new bill does nothing to replace existing regulatory structures with the modern legal structure needed to regulate an increasingly complex pharmaceutical and medical device industry while protecting the public. health and patient rights.

Who should staff the new regulator? A parliamentary standing committee on health and family welfare first raised concerns about the people who make up India’s drugs regulator, the Central Drug Standard Control Organization (CDSCO). It is run by a qualified bureaucracy mainly in pharmacy. Other drug regulatory authorities in developed countries have multidisciplinary teams of professionals usually led by a physician with a background in public health.

India has yet to understand drug regulation as just a manufacturing issue for a public health concern. Technically, the qualification criteria of the Drugs and Cosmetics Rules of 1945, for entry level positions as Drug Inspectors and the senior post of Drug Controller General of India (DCGI), allow physicians to be appointed to these positions. However, this criterion is accompanied by a requirement to have 3 and 5 years of experience in the manufacture or testing of drugs respectively.

While doctors are employed by pharmaceutical companies, they are rarely involved in the manufacture and laboratory testing of drugs, their role being in clinical research. This absurd qualification criterion continues despite the agreement of a GoI expert committee with the parliamentary commission. At the state level, the situation is worse. In Telangana, the state drug controller has always been an Indian Police Service (IPS) officer, as the state regards drug regulation as a matter of “law and order”. In Andhra Pradesh, an Indian Revenue Service (IRS) officer dedicated to tax collection has been appointed as the national drug controller.

The new bill does nothing to correct this situation. Instead, it delegates power to state governments and the Indian government to decide the qualification criteria for their respective drug control officers. This is different from the existing law where the Indian government has set the qualification criteria for drug inspectors and licensing authorities across the country. The Ministry should consider providing qualification criteria in the text of the bill and ensure that a modern regulatory body is staffed with specialists in pharmacology, medicine, chemistry and the regulatory sciences of biology .

Creation of an independent regulator: The bill does nothing to improve the archaic status of the CDSCO. Prior to the 1990s, regulators did not have an independent legal existence. They fell under the jurisdiction of the GoI. This basically meant:

* Regulators would be bound by all the cumbersome GoI rules ranging from recruitment to financial powers.

*They would have no “regulatory” powers. All requests to create or change rules would be directed to the ministry secretary, usually an IAS officer who may or may not have expertise on the subject.

*Regulators could be overridden by the ministry overseeing certain matters. For example, the Drugs and Cosmetics Rules clearly provide for an appeal against the decision of drug controllers to the central or state government, thus allowing the minister acting on the advice of a lay bureaucrat to overrule expert regulatory decisions.

After liberalisation, a new regulatory model was introduced with the establishment of regulators like the Securities and Exchange Board of India (Sebi), Telecom Regulatory Authority of India (Trai), etc. Each of these regulators was “independent”, not in the sense of judicial independence, but in the sense that they were created with their own corporate existence separate from the GoI.

This meant that although they were still accountable to a ministry and an elected minister, they could create their own recruitment and financial rules, allowing them the flexibility to operate with less bureaucracy and hire better talent laterally into the sector. private. More importantly, they were also given a limited degree of rule-making power so that they could react more quickly to situations on the ground.

The new bill misses the mark on this issue, despite 2013 legislation that never passed through parliament actually proposing this model for a new medicines regulator. To date, the CDSCO is an office attached to the General Directorate of Health Services (DGHS), itself a department of the Ministry of Health reporting to the secretariat. Simply put, CDSCO and DCGI who run it are far from the center of power.

The Government of India also has a “Drugs Regulatory Section” under a Joint Secretary with rule-making powers under the Drugs and Cosmetics Act 1940. It has the power to “ban” drugs although it has no real role in approving drugs. That the Ministry of Health wants to continue with this obsolete structure gives a bad image of the committee responsible for drafting this new law.

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