DCGI initiates review of pharma manufacturing standards to ensure drug quality and safety


India’s drug regulator plans to review pharmaceutical manufacturing standards to ensure the quality, safety and efficacy of drugs following instances of substandard locally produced drugs.

The Drug Controller General of India (DCGI) will meet pharma industry associations today to discuss reviewing Schedule M that lays down Good Manufacturing Practices (GMP) for pharma companies. This is aimed at enabling better quality management to help these companies grow their business locally and overseas.

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The regulator has asked industry associations like The Organisation of Pharmaceutical Producers of India (OPPI), Indian Drug Manufacturers Association (IDMA), CII, BDMA, IPA, FOPE, Assocham to attend the meeting.
The government had issued a draft notification in 2018 to upgrade Schedule M and synchronise it to international standards. However, the draft couldn’t be finalised. Considering the importance of GMP compliance in ensuring the quality of drugs, the government has decided to finalise the draft rules, transiting from the existing Schedule M to revised Schedule M.
Earlier in August, Union health minister Mansukh Mandaviya had said that pharma companies having annual revenues of more than Rs 250 crore will have to mandatorily adopt GMP within six months and those with revenues of less than Rs 250 crore will have to do so within 12 months. He also said those who fail to follow the timelines may be penalised. The GMP system was first incorporated in 1988 in Schedule M of the Drugs and Cosmetics Rules, 1945, and was last amended in 2005. The drug regulator had recently carried out risk-based inspections and pointed to an urgent need to relook the current GMP regulations and quality management systems being followed by pharmaceutical companies.The government had earlier this year carried out raids in more than 75 pharmaceutical companies in various states. Over 25 companies were found to be in violation of regulations and were issued show cause notices.As per data from the Central Drugs Standard Control Organisation (CDSCO), there are around 10,500 drug manufacturing units in the country, which produce various types of dosage forms and APIs.

Over the last few months, several cases have emerged wherein products exported by Indian pharmaceutical companies were found to be of inferior quality.

The World Health Organization (WHO) in October last year said the deaths of dozens of children in Gambia from acute kidney injuries might be linked to contaminated cough and cold syrups made by an Indian drug company. The drug regulator has also started collating and compiling profiles of pharmaceutical plants in the country to ensure product quality.

The regulator has asked drug companies to provide details of each of their operational units. Companies have also been asked to share information on approvals obtained from the European Union, US Food and Drug Administration and other regulatory bodies overseas.

Known as the pharmacy of the world, India is a major exporter of medicines to lower and middle-income countries, which require the WHO Good Manufacturing Practices (WHO-GMP) certification. Around 2,000 pharma units in the MSME category have this certification.

Credits – Source – https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/dcgi-initiates-review-of-pharma-manufacturing-standards-to-ensure-drug-quality-and-safety/articleshow/103676394.cms


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