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DCGI calls for suggestions from industry to reduce compliance burden

Pharma associations are likely to submit their recommendations by early next month

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The Drug Controller General of India (DCGI) has asked industry associations to submit their representations highlighting aspects or issues in the Drug and Cosmetics Rule 1945 that can be made redundant to reduce the compliance burden on the industry.

In a recently held webinar, ‘Reducing Regulatory Compliance Burden’, the DCGI interacted with industry representatives from IDMA, BDMA, FOPE, OPPI, CIPI, HDMA – Laghu Udyog and asked them to highlight regulatory issues faced by the industry.

Some of the associations have already submitted their representation, whereas many of them are likely to submit it by early next month.

The IDMA representative requested that instead of making Schedule M mandatory it should be in the form of guidelines. The IPA representative expressed that the implementation of Schedule M should be done at the earliest.

IDMA suggested making separate rules for excipients and disinfectants and also pointed out that there is a need to properly define APIs and NSQs to avoid misinterpretation.

The association also highlighted issues pertaining to shelf-life of formulations. It said that in the current scenario, shelf-life of formulations is not allowed to go beyond the shelf-life of APIs. It also stressed that bulk drugs which are exported and returned for reasons of non-compliance of physical parameters like moisture, particle size and bulk density should be permitted to be sold in the domestic market. It is not allowed currently.

Similarly, HDMA and IPA requested for QR codes on APIs. BDMA will be preparing a detailed report to submit to the regulatory authority on joint inspection for WHO certification which is taking a long time.

During the session, the association representatives also suggested creating Centre-State Committees wherein industry experts can also join. And these Committees can help in updating the guidelines as is done in the WHO.