India to inspect small drug manufacturers for compliance

India's regulatory body for drug manufacturing will begin random inspections of small drug companies by the end of this year. This initiative aims to ensure these companies follow good manufacturing practices (GMP) and improve drug quality. The Central Drugs Standard Control Organisation (CDSCO) plans these checks after a deadline for companies to upgrade their facilities. Currently, only a few small firms have applied for extensions, though many need to comply with new standards set by the government. The checks will help address concerns about the quality of drugs made in India. Companies that do not meet GMP requirements may face penalties, including possible factory closures. A government official noted that the state governments might also be involved in the inspections. As of now, around 2,000 pharmaceutical units in India have GMP certification, mainly large companies. In contrast, about 8,500 small and medium enterprises (MSMEs) are yet to improve their plants. These MSMEs represent over 80% of the drug market by volume in India. Industry leaders are encouraging small drug firms to upgrade their facilities. Harish Jain, president of the Federation of Pharmaceutical Entrepreneurs, stated that they are educating members on how to apply for GMP compliance and emphasizing the importance of these upgrades for business prospects. India is a major player in the global generic drug market, producing around 60,000 generic medicines, which account for 20% of the world’s supply. The country aims to boost its reputation in drug manufacturing through stricter quality controls.