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Ramesh Shankar
Wednesday, October 13, 2021, 08:00 Hrs  [IST]

The Union Health Ministry has recently constituted an eight-member panel for framing a new law for drugs, cosmetics and medical devices. The panel, headed by Drugs Controller General of India (DCGI) Dr V G Somani, will frame a new Drugs, Cosmetics and Medical Devices Bill. The high-powered committee is empowered to undertake pre-legislative consultations and examine the present Drugs and Cosmetics Act, previously framed Drugs and Cosmetics Bills and submit a draft document for a de-novo Drugs, Cosmetics and Medical Devices Bill by November 30, 2021. The present Drugs and Cosmetics Act, 1940 regulates the import, manufacture, distribution and sale of drugs, cosmetics and medical devices. This Act is amended from time to time and the last amendment in the Act was made in 2008. In fact, the Drugs and Cosmetics Act was enacted in 1940 when India was under colonial rule and a net importer of drugs. Even by the year 1970, the total turnover of the domestic pharma industry of India stood at Rs. 300 crore.  Now, things have taken a sharp turn for the better as India is now a leading global manufacturer and exporter of drugs, aspiring to climb up the value ladder. Today, the domestic pharmaceutical industry in India has reached a whopping Rs. 1.5 lakh crore, and an equal amount for exports.  It is a fact that over the years, the Health Ministry has introduced changes in the Drugs and Cosmetics Act and Rules to tackle the emerging regulatory challenges with the concomitant rapid expansion of the pharma market.  However, attempts at piecemeal regulation of the emerging challenges over the years have led to certain contradictions and lack of harmonization between various aspects of the amendments introduced in the Act. Against this background, an overhaul of the Act was long overdue.

All said and done, the constitution of the committee in its wake has brought some controversies over the lack of representation to the industry in the panel.  Out of the eight members, five are from CDSCO and the other three are also not from the industry. There is need for cooperation between industry and the regulator while framing new rules or even examining the current regulations. There are many aspects of rules which the industry faces problems in adhering to. So, there is need for industry’s presence on the committee to offer constructive suggestions. Definitely, the Committee will remain incomplete without representation from the stakeholders. Regulations are meant for the industry and trade in the interest of health of the common man.  In the absence of their representation, it would be difficult for them to finalise the provisions of the Drugs and Cosmetics Act. Moreover, the lack of representation from pharmacy trade, e-pharmacy, pharma manufacturing, and research besides cosmetics and medical device industry is also a glaring mistake by the government. It is not practical for the Committee to seek comments from the industry for the new Act in two months considering the inputs to be provided to frame proper provisions for the present-day pharma and medical device industry environment and patient health.Since India is the pharmacy of the world, the new regulations should be current, innovative, with a future perspective to think at different levels. The government should revisit the constitution of the Committee to give proper representation to the stakeholders.


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