In recent times 36% of pharmaceutical manufacturing units inspected by the Indian drug regulatory and forced to shut down for not complying with quality standards. Since December 2022 Central Drug Standard Control Organisation (CDSCO) conducting risk-based inspections of manufacturing facilities.
Drug Controller General of India (DCGI) Rajeev Raghuvanshi at the Global Pharmaceutical Quality Summit, 2024 (Indian Pharmaceutical Alliance) said, “About 400-odds units were inspected and nearly 36 per cent had to be closed as they failed to meet standards. Around 10 per cent of units were permanently shut down as they realised they would not be able to comply with quality standards and the remaining units came out with preventive plans of action”.
There are around 10,000 manufacturing units in India, of which nearly 80 % are micro-scale and medium-scale facilities. Most of the pharma units fail to document and validate the process. Further Summit Raghuvanshi said, “There have been no significant international quality complaints since July 2023 but earlier we were getting two complaints every other month.” While talking about international complaints Raghuvanshi hinted Gambia cough syrup controversy where children died in the African nations, after consumption of cough syrups made in India. CDSCO is stepping up efforts to make pharmaceutical units follow standard practices to increase quality. CDSCO started auditing with inspecting manufacturing sites then moved to public testing labs and now it has been moved to clinical research organisation (CRO). CDSCO inspected around 600 units. On July 1, the regulator from CDSCO will start auditing large pharma units to check compliance with Schedule M guidelines. Drug and Cosmetic Rules 1945 advise Good Manufacturing Practice. The regulator from CDSCO is planning to increase manpower for the auditing of large pharmaceutical units.
Raghuvanshi said, “This is a big gap that we have identified. There is no specific cadre to review on this and will move forward soon.” CDSCO is planning to take tough measurements to ensure commitment to good practice with the organisation. He also added that due to departmental malpractice, it led to the termination of employees from CDSCO). Internal auditing has been initiated and CDSCO is looking into auditing and process for improvements.
The Digital Drug Regulatory System (DDRS) is an umbrella portal for everything related to pharmaceutical regulations and requests for this system have been floating around. In that system supply chain track-and-trace mechanism will also be added to track raw material sources. Raghuvanshi also added that it is an idea or system that will have all the structure from raw material to patient under the same roof.
