India s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has discovered the widespread use of industrial-grade excipients, unfit for human consumption, in the country s pharmaceutical manufacturing. Following international complaints, the CDSCO conducted investigations and inspections, revealing that unlicensed traders supplied industrial-grade gelatin, propylene glycol, and other excipients to pharmaceutical manufacturing units.
Substandard medicines, insufficient training, lack of quality culture, data integrity and more – an internal assessment of Indian pharmaceutical companies has exposed significant lapses during inspections across India.
More than 75% of the firms have also been issued show cause notices, the people said. Out of the total samples drawn from these manufacturing units, 15.1% have so far been declared to be of not of standard quality (NSQ). The regulator is currently conducting Phase IV of these inspections.
The Drugs Controller General of India (DCGI) has announced that manufacturers and importers of high-risk medical devices who have applied for a license before September 30 can continue to supply them in the market for another six months. New regulations state that medical devices in the class C and class D categories cannot be sold without a license. Many manufacturers have applied for licenses but have not received them on time. The government s think tank, NITI Aayog, has recommended that all medical devices meet safety and quality standards.