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Shardul Nautiyal, Mumbai March 20 , 2023
Drug regulatory experts have advocated for decriminalizing the existing drugs act without compromising on the drug quality and patient safety.

The point of contention, they pinpoint, is that if any retailer and manufacturer fails to display the license in a prominent place and is not conspicuous to the public, it amounts to violation of the condition of the license and a violation of the Rule 65 of the existing Drugs Act. It is a criminal offence under Section 18 and is punishable as described under Section 27. 

A number of industry representations have also been made to suggest removal of the provisions related to prosecution for offences other than the ones related to manufacture of spurious, adulterated and NSQ drugs causing death or grievous hurt (Section 27 (a), 27 (b) and 27 (c) cases).

“These kinds of anomalies and ambiguities in our current drugs act will impact our prospects of self reliant India and ease of doing business,” according to Gujarat FDCA Commissioner Dr HG Koshia.

Further in the absence of defense of mens rea (not considering the intention behind the non-compliance), any unintentional, minor departure from the practices for the manufacture of medicines is considered as an offence and such manufacturer or dealer or any person is exposed to stringent penalty under the Act.

D&C Act is an Act to regulate the import, manufacture, distribution and sale of drugs to ensure availability of safe and efficacious medicines. Every requirement under the Act and Rules assumes mandatory nature and thus the Act imposes the concept of absolute liability.

The Central government had constituted a committee to frame the New Drugs Bill. Suggestions, comments and objections were invited from the public and stakeholders with regard to the draft Bill, within a period of 45 days from the date of issue of notice.  The legislation has not been enacted as yet.

The draft includes provisions through which the Central Licensing Authority (CLA), can in public interest, abbreviate, defer or waive offer such pre-clinical and clinical data requirements for approval of such new drug, relating to life threatening of serious diseases or rare diseases or diseases of special relevance to the country, in such manner as may be prescribed.

One of the members of the committee which was constituted under the Drugs Controller General of India (DCGI) along with state drug controllers of Gujarat, Haryana and Maharashtra during the Covid pandemic to frame the New Drugs, Medical Devices, and Cosmetics Bill of 2022 clarified that there is no talk about the Union government, in its New Drugs, Medical Devices, and Cosmetics Bill, proposing that the country's apex drug regulatory body — the Central Drugs Standard Control Organisation (CDSCO) — be empowered to regulate the manufacture of drugs or cosmetics.

The proposed Schedule M that adopts the guidelines for GMPs makes compliance with the guidelines mandatory which makes the compliance very challenging for the Indian manufacturers.

Industry has therefore also urged that the requirements of GMP shall be amended to include the principles and concepts in the Acts and Rules, while the details shall be in the form of guidelines and advisories. The guidelines shall be dynamic and the power to issue the guidelines and changes shall be with the DCGI.

The Union health ministry had in July 2022 released the draft of New Drugs, Medical Devices and Cosmetics Bill, 2022, a comprehensive legislation with provisions to regulate medical devices, clinical trials and online pharmacy, among others in order to keep pace with changing needs, times, and technology as against the pre-independence legislation of the D&C Act, 1940.

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