To enhance the quality of many Indian drugs pharma industry, the Centre
in collaboration with the Indian Drugs Manufacturers’ Association (IDMA) has planned
to celebrate the first ever National Current Good Manufacturing Practice Day
(cGMP Day) on October 10.
IDMA secretary general Daara B Patel said, “This day shall be
dedicated to entire pharmaceutical industry to create awareness on the cGMP
guidelines. The image of the Indian pharma industry has been affected badly due
to multiple reports of poor-quality cough syrups aboard. Hence, we want to
establish GMP rules as a part of our good practices and routine.”
Emphasizing that quality has no substitute, mainly in this sector,
Patel stated the GMP rules are the backbone of pharmaceutical manufacturing
operations and help manufacturers prevent non-compliance.
It thereby protects the quality of medicinal products, as mandated
by the World Health Organization (WHO), prescribes essential standards to
enhance product quality through controlled measures related to materials,
methods, machinery, processes, personnel, facilities, as well as the
environment, he added.
Right now, GMP under Schedule M of the Drugs and Cosmetic Rule is
under review wherein it will become applicable for all pharmaceutical companies
are around 10,500 drug manufacturing units in the country, out of which only
2,000 have WHO GMP certification.
Under the proposed amendment in Schedule M of Drugs and Cosmetics
Rules, 1945, the Centre has given a period of six months for large companies
(with a turnover exceeding ₹250 crore) and 12 months for MSMEs (below ₹250
crore) to implement upgraded GMP standards.
Officials from Bharat’s Health Ministry, United States Food and
Drug Administration, Medicines and Healthcare products Regulatory Agency,
CDSCO, pharmacy schools, and academia are expected to take part.
NE Watch Desk
