The ministry of health has decided to revise regulations pertaining to manufacturing practices under Schedule M of the Drugs and Cosmetics Rules of 1945 to make them on par with the World Health Organisation good manufacturing practice (WHO-GMP) standards.
A draft proposal to amend the D&C Rules to modify the schedule has come close on the heels of an interest subvention scheme announced by the government to facilitate small pharmaceutical companies upgrade their technology and infrastructure to meet WHO-GMP norms.
According to industry sources, the proposed Schedule M revision has come as no surprise as the government is getting ready to implement uniform standards for drug manufacturing industry ahead of joining the Pharmaceutical Inspection Cooperation Scheme (PICS), a global mechanism to improve cooperation in GMPs between regulators.
At present, while majority of small and medium 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.
“The process to join PICS would take at least five years, but it will promote our drug exports by offering greater market access. Most countries only accept import and sale of medicines that have been manufactured to internationally recognised GMP. The move to revise Schedule M is adopted in order to fulfil this objective,” a CDSCO official said.
The draft document, reviewed by Pharmabiz, details various requirements of premises, plant and equipment for manufacturing pharmaceutical products. GMP will be applicable to life-cycle stages from the manufacture of investigational medicinal products, technology transfer and commercial manufacturing, to product discontinuation. The quality system can extend to the drug development stage and shall facilitate innovation and continual improvement and strengthen the link between pharmaceutical development and manufacturing activity.
The revised norms underscore provisions for regular quality checks, procedure for self-inspection and periodic management reviews. In accordance with GMP, each company should identify what validation work is required to prove that its critical operational aspects are controlled. The key elements of validation must be defined and documented in a master plan. There should also be a system in place to recall defective products from the market.
According to the notification, the proposed changes in rules won’t apply to presently licensed manufacturers until October 31, 2020. The firms are expected to evolve methodology, systems and procedures to implement these changes that should be documented and maintained for inspection and reference. The draft proposal is open for comments and suggestions from industry stakeholders till November 5.