At a time when the Union health ministry is in the final stages of releasing a draft guideline towards enhancement of GMP to align India-specific standards with global regulations for better product quality of pharmaceutical products, states like Gujarat are taking proactive measures to spruce up their drug regulatory mechanism.
Approximately 1,400 manufacturing units in India are WHO GMP certified, and over 800 are UK MHRA approved. India continues to have the highest number of US FDA registered manufacturing facilities outside the US. The industry has strong capabilities in product development. Also, Indian pharmaceutical companies have the largest share of DMFs and ANDAs outside the US. However, global GMP violations have recently hurt India’s image as an inexpensive and reliable supplier of generic drugs in international markets.
For the last two years, industry and Department of Pharmaceuticals (DoP) have jointly held a series of workshops for small and medium companies aimed at imparting technical skills and improving regulatory and quality standards of manufacturers.
Central Drugs Standard Control Organisation (CDSCO) also plans to bring about uniformity in inspections of Schedule M units across the country as a part of its programme to upgrade Schedule M units to WHO-GMP standards.
Drug Controller General of India (DCGI) in October 2016 proposed that the validity of licenses be made ‘perpetual’ and also that Schedule M GMP may be updated to be on par with WHO GMP. Industry had also made a submission to DCGI welcoming the same. It was suggested that while the focus of Government is on ease of doing business for industry, it would be beneficial to the manufacturers if the same facility is allowed to manufacture different types of medicines (including for humans and veterinary) as well as ayurvedic, phytopharmaceuticals, nutraceuticals and cosmetics, as long as specific GMP approvals as required for manufacture of drugs are complied with.
DCGI had earlier submitted a proposal to the Union health ministry to mandate upgradation of Schedule M units across the country to WHO-GMP level under the purview of drug rules towards good manufacturing practices adopted globally. This is aimed at taking steps further towards global regulatory harmonisation for making quality drugs.
Gujarat FDCA initiatives
As a step towards increasing compliance in cases related to counterfeit drugs, spurious drugs and not-of-standard Quality (NSQ) drugs, the Gujarat Food and Drug Control Administration (FDCA) has successfully trained 50 drug control officers on Good Manufacturing Practices (GMP) and has rolled out new modules moving forward.
The training which has equipped drug inspectors to detect cases of faulty medical devices and sub-standard drugs in line with the training imparted to US FDA inspectors has been done through a collaboration with US-based Underwriters Laboratories (UL), a global safety consulting and certification company. UL EduNeering, the compliance education and training services business division of UL, led this initiative.
Following its collaboration with French and US based companies to help its officers train in terms of analysing drug samples and auditing manufacturing units, the Gujarat FDCA has now collaborated with Abbott India to train and equip FDCA officers on medical devices and other testing modalities as a part of strategic partnership for knowledge sharing at the recently concluded Vibrant Gujarat Global Summit (VGGS) - 2017 at Gandhinagar.
The Gujarat government signed eight such strategic partnerships with overseas and Indian companies to upgrade the knowledge of the Gujarat FDCA officers on relevant areas of concern challenging the regulatory authorities globally and in India.
Training which also includes Good Distribution Practices (GDP) and Good Laboratory Practices (GLP) had earlier equipped 45 drug inspectors on 22 online courses through this initiative based on an MoU signed with UL during Vibrant Gujarat Summit in January, 2015.
Says Gujarat FDCA Commissioner Dr HG Koshia, “Done as a part of strategic partnerships for knowledge sharing with foreign companies, the training programme is primarily conducted through an e-learning mode to help drug inspectors get access to world-class training on par with global counterparts. The best part of this initiative is that this has led to increase in detection of spurious drugs and NSQ drugs.”
UL is offering about 700 such courses of which 125 courses are authored by the US Food and Drug Administration (US FDA). Since Gujarat has over 3,000 manufacturing facilities catering to formulations and active pharmaceutical practices (APIs), it has adopted only about 150 relevant courses.
He further added that the online course would also help the drug inspectors conduct inspection on the shop floor of a drug facility in an effective way. There is no monetary interest associated with offering this online programme as the aim is to empower the central and state drug investigators with the similar regulatory knowledge as that is offered to the US FDA.
The programme is intended for drug inspectors, senior drug inspectors, assistant drug commissioners, deputy drug commissioners and drug commissioners. UL offers about 1,200 courses globally and has trained around 38,000 US FDA inspectors.
The Gujarat FDCA is also planning to collaborate with France based bioMérieux to train and equip FDCA officers on rapid microbial testing as a part of their strategic partnership.