Policy To Allow Only GMP Compliant Drug Manufacturers In Consideration

New Delhi, Aug 22 (KNN) The Drugs Controller General of India (DCGI) is contemplating a significant policy shift in pharmaceutical licensing, potentially issuing and renewing licenses only to firms that demonstrate adherence to Good Manufacturing Practices (GMP).

This move comes as India's pharmaceutical industry, currently valued at USD 65 billion, faces scrutiny over quality control issues, reported Livemint.

GMP standards, outlined in Schedule M of the Drugs and Cosmetics Rules, 1945, establish comprehensive guidelines for pharmaceutical manufacturing, encompassing raw materials, methods, equipment, processes, personnel, facilities, and environmental factors.

The Indian Health Ministry mandated GMP compliance in December 2023, though industry adoption has been gradual.

The Drugs Consultative Committee (DCC) addressed this matter in a June meeting, recommending nationwide implementation of the December 2023 rules.

Consequently, both central and state licensing authorities are expected to assess GMP compliance when considering license issuance or renewal.

The December 2023 notification set a six-month compliance deadline for companies with annual revenues exceeding Rs 250 crore, while smaller firms were given a 12-month window.

This initiative aims to elevate India's drug manufacturing standards to global levels, particularly those set by the World Health Organisation (WHO).

The urgency for enhanced quality control was underscored by recent incidents linking contaminated Indian cough syrups to child fatalities in Gambia and Uzbekistan in 2022.

As the primary supplier of medicines to low- and middle-income countries, India's drug quality has far-reaching implications.

Currently, of the 10,500 drug manufacturing units in India, only 2,000 possess GMP certification, primarily larger enterprises.

The remaining 8,500, mostly small businesses, lack this certification.

Regulatory bodies, including the Central Drugs Standard Control Organisation (CDSCO), DCGI, and state drugs controllers, have intensified inspections since last year.

Approximately 400 premises, including MSMEs, have undergone inspection, with some samples failing quality standards.

The Union Health Ministry reported on August 2 that state licensing authorities have taken over 300 regulatory actions, ranging from show cause notices to license cancellations.

Industry representatives have expressed support for these quality assurance measures. Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance (IPA), welcomed the initiatives, noting their alignment with international standards.

Similarly, Daara Patel of the Indian Drugs Manufacturing Association affirmed that member companies are adhering to GMP standards and efforts are ongoing to educate the industry about compliance requirements.

This regulatory tightening represents a significant step towards ensuring the global competitiveness and reliability of India's pharmaceutical sector.

(KNN Bureau)