Government Urges Pharma Msmes To Upgrade For WHO-GMP Compliance

(MENAFN- KNN India) New Delhi, Jan 14 (KNN) In a decisive move to enhance the quality of life-saving medicines, the Indian government has mandated that micro, small, and medium enterprises (MSMEs) in the pharmaceutical sector submit detailed action plans for plant upgrades to meet World Health Organisation (WHO) Good Manufacturing Practices (GMP) standards.

These plans must be submitted within three months, with the compliance deadline set for December 31, 2025, as reported by Mint.

Failure to comply will result in the shutdown of non-compliant units, according to government officials.

This directive follows a troubling trend of domestically produced drugs failing international quality tests due to alleged contamination.

Of the 10,000 MSME drug manufacturers in India, only 2,000 currently adhere to WHO-GMP standards.

GMP norms ensure stringent control over materials, processes, equipment, and personnel to consistently produce high-quality medicines.

These guidelines are pivotal for protecting public health and bolstering India's reputation in the global pharmaceutical market.

To support compliance, the government revised Schedule M of the Drugs and Cosmetics Rules, 1945, in 2023, outlining phased implementation of GMP standards.

While larger companies were given six months to comply, smaller firms were initially granted one year, recently extended to December 2025 for those with revenues under Rs 250 crore.

Industry leaders, however, argue that the timeline remains insufficient. Harish Jain Manawat, president of the Federation of Pharmaceutical Entrepreneurs (FOPE), emphasised the challenges MSME drugmakers face, including financial constraints, manpower shortages, and the technical complexities of upgrading infrastructure.

FOPE has requested a further two-year extension while urging its members to act swiftly.

“Upgrading facilities to meet GMP standards requires significant investment and training,” Manawat said, adding that nearly 50 per cent of FOPE's member firms are still in the early stages of compliance.

The government's renewed focus on drug quality has also prompted the launch of the Revamped Pharmaceuticals Technology Upgradation Assistance Scheme, which offers financial support to help manufacturers meet global standards.

As the clock ticks, the pressure is mounting on smaller pharmaceutical companies to align with international quality benchmarks, ensuring the safety and efficacy of medicines made in India.

(KNN Bureau)

MENAFN14012025000155011030ID1109087543