DCGI Calls Upon Indian Pharma for Raise Standards to Global Level

India Pharma Outlook Team | Thursday, 26 October 2023

 India Pharma Outlook Team

India, being the prominent manufacturing hub for pharmaceuticals catering to the medicinal needs of the global population, requires Indian companies to uplift their manufacturing processes to meet global standards, as highlighted by Dr. DCGI, the Drug Controller General of India. Rajiv Singh Raghuvanshi In light of the concerns highlighted by regulators from foreign countries regarding the quality of Indian made pharmaceuticals, he emphasized that he is making this statement. The Indian drug regulator has confirmed that the government has received 18 international alerts over the past nine months. This has prompted the government to consider upgrading the current good manufacturing practices (cGMP).

The revision of these practices is currently being planned, as per pharmabiz. Raghuvanshi, the esteemed chief guest, was delivering a speech at a function held in Chennai. This event was organized by the Tamil Nadu drug manufacturers, as a component of the Regional Workshop on the Revised cGMP for pharmaceutical manufacturers within the state. According to him, the CDSCO has organized 13 workshops across the country aimed at familiarizing drug manufacturers with the latest provisions outlined in the New Schedule M. After attending the Baddi workshop, the DCGI was now participating in his second program. The purpose of this program was to provide elaborate explanations regarding Schedule M. The national drug regulator, while engaging with industry professionals, highlighted quality assurance (GMP) as the primary hurdle hindering the country from reaching global standards. He mentioned that while India supplies pharmaceuticals to approximately 200 countries, there exist a handful of companies lacking knowledge on manufacturing products that adhere to international standards. Upon conducting inspections at the production facilities, regulators have identified that certain companies are facing the challenge of either a lack of skills or a lack of interest. For NSQs, Dr. needs to be taken into consideration. Raghuvanshi pointed out that some companies also manufacture duplicate batches of subpar quality products. This indicates a lack of understanding regarding the correct procedures for pharmaceutical preparations according to the Indian Pharmacopoeia by the companies.