The Indian government is taking steps to support small and medium-sized pharmaceutical companies facing increased scrutiny from global regulators. With recurring lapses in the quality and manufacturing practices of these drugmakers, the government aims to assist them in navigating regulatory requirements effectively.
The Ministry of Commerce and Industry’s pharmaceutical export wing, Pharmexcil, in collaboration with the Ministry of Health and Family Welfare, proposed the concept of “capacity-building workshops” to improve the good manufacturing practices of MSME drugmakers. These workshops will be conducted in partnership with the Central Drugs Standard Control Organization (CDSCO), India’s apex drug regulatory agency responsible for regulating the quality and standard of drugs in the country.
The one-day regional workshops will be held in more than 10 locations across India, including Delhi, Ahmedabad, Hyderabad, Chandigarh, Indore, Chennai, Bangalore, Mumbai, Sikkim, Visakhapatnam, and Goa. The inaugural workshop is scheduled to take place in Delhi on September 15, with additional workshops planned for Baddi and Hyderabad on September 16.
The need for these workshops arises from complaints raised by multiple global health regulators regarding the quality of Made-in-India medicines. The World Health Organization, Uzbekistan, the Gambia, the United States, Marshall Islands, and Micronesia have all expressed concerns about the non-compliance of Indian pharmaceutical companies with good manufacturing practices and product quality norms. Such incidents have tarnished the image of the Indian pharmaceutical industry and led to fatalities caused by the supply of contaminated medications.
Uday Bhaskar, the director general of Pharmexcil, emphasizes the objective of the capacity-building program is to raise awareness of best international practices for pharmaceutical manufacturing among MSME drugmakers. This program aims to aid them in maintaining the quality of their products and improve the image of the Indian pharma industry. Currently, only around 2,000 out of approximately 8,500 MSME manufacturing units in India are approved by the World Health Organization and certified as WHO-GMP compliant.
To ensure maximum participation, the Drug Controller General of India (DCGI), the chief of CDSCO, has sent a letter to all drug manufacturing associations informing them about the schedule of the planned workshops. The letter highlights the dissemination of Revised Schedule M requirements to all stakeholders and mentions the tentative workshop schedule across various cities in India.
In August, the central government decided to implement ‘Schedule M’ across all pharmaceutical companies in India. This move aims to tighten manufacturing practices and enhance the overall quality standards of the industry.
By providing support and guidance through these capacity-building workshops, the Indian government is taking proactive steps to address regulatory compliance issues faced by small and medium-sized pharmaceutical companies. It is hoped that these initiatives will improve the quality of medications produced in India and restore the reputation of the Indian pharmaceutical industry on the global stage.