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Industry urges union health ministry to give suitable time frame to SMEs to upgrade to GMP standards
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Shardul Nautiyal, Mumbai
December 12 , 2018
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In order to help SMEs and domestic industry to upgrade to WHO-GMP standards, the Indian Drug Manufacturers Association (IDMA) has urged the union health ministry to give suitable time frame to SMEs to adopt the new GMP draft guidelines before they are formed into norms looking into their requirements and frame a guidance document on the same.
The industry association will submit its recommendations to the ministry on the proposed move to revise GMP norms by December 15, 2018.
The guidelines which need to be adopted as a part of the global harmonisation process will enhance the capacities of the domestic industry and help them to participate in public healthcare tenders and 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 two months ago. 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 over the measure as many of them have to shell out exorbitant amounts of money to implement it, which would be a drag on the sector already troubled by steep rise in active pharmaceuticals ingredient (API) costs.
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.
According to official sources, the revised Schedule M will not come into force until suggestions from the domestic industry are reviewed.
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.
It is high on Government agenda to implement uniform standards for drug manufacturing industry ahead of joining the Pharmaceutical Inspection Cooperation Scheme (PICS), a global mechanism to improve co-operation in GMPs between regulators.
The draft document 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.
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