Industry raises concern over incorporation of strict WHO, ICH Guidelines in Schedule M
Alarmed at the risk of being penalised for minor discrepancies, the Indian drug manufacturers have raised concern over incorporation of strict WHO and ICH Guidelines in Schedule M.
At present, while majority of small and medium drug manufacturers in India comply with Schedule M, only around 20 per cent of the firms meet WHO-GMP norms, leading to dual standards of quality.
Schedule M is a part of Drug and Cosmetic (D&C) Act 1940. It stipulates good manufacturing practices (GMP) for manufacturing medicines that should be followed by pharmaceutical manufacturing units in India.
GMP and requirements of premises, plant and equipment for pharmaceutical products are currently covered under Rules 71, 74, 76 and 78 of Schedule M.
“By incorporating the WHO and ICH Guidelines as Rules, manufacturers are at a greater risk of being penalised for minor discrepancies, which will otherwise be acceptable without impacting the quality of the product,” according to a representation made by the Indian Drug Manufacturers Association (IDMA) to the Union health ministry.
Union health ministry had issued a draft notification in October 2018 seeking to revise and upgrade Schedule M.
According to IDMA office bearers, “Government is now focusing on acquiring Pharmaceutical Inspection Cooperation Scheme (PICS) membership and was working towards that by proposing drastic revision of Schedule M based on WHO and ICH Guidelines.”
“The proposed revision requires a revisit to include relevant and specific additional requirements based on WHO Guidelines and EU systems. The rest such as PQS and other additions can be issued as Guideline,” IDMA in its submission stated.
According to the Drug Controller General of India (DCGI), WHO- GMP guidelines need to be adopted as a part of the global harmonisation process. This will enhance the capacities of the domestic industry and help them to participate in public healthcare tenders and also help seek financial and other incentives from the government.
The union health ministry had floated the draft amendment to Schedule M for making it on par with the World Health Organisation-GMP (WHO-GMP) standards last year. It had left the draft proposal open for inputs from stakeholders till November 5, 2018. But industry stakeholders had sought more time to submit their suggestions, considering the path-breaking nature of changes proposed in the draft amendment.
Small and medium pharmaceutical manufacturers are worried about the move as most of them have to shell out huge amount of money to implement it, which would be a drag on the sector already troubled by steep rise in active pharmaceuticals ingredient (API) costs.
While the proposed changes in rules will not apply to presently licensed manufacturers until October 31, 2020, industry representatives point out that if amended rules of Schedule M come into force, each drug manufacturing firm will have to shell out up to Rs.6 crore which is an expensive proposition for many SMEs.
Government is keen to implement uniform standards for drug manufacturing industry ahead of joining the PICS, a global mechanism to improve co-operation in GMPs between regulators.
PICS is a non-binding, informal co-operative arrangement between regulatory authorities in the field of GMP of medicinal products for human or veterinary use. It is open to any authority having a comparable GMP inspection system.
The guidance draft document details various requirements of premises, plant and equipment for manufacturing pharmaceutical products. It also covers life-cycle stages from the manufacture of investigational medicinal products, technology transfer and commercial manufacturing to product discontinuation.