- 28 Jun 2024
- ICICI Securities
DGCI to start four key projects for improving and maintaining quality of drugs
News: Central Drugs Standard Control Organization (CDSCO) inspected 400 MSME pharma players and informed that around 36% of players are lacking the quality/risk standard.
To improve and maintain the quality standards CDSCO is starting 4 key projects : 1)CDSCO will aboard all the stakeholders involved in the value chain from regulatory bodies to manufacturers and retailers onto one platform to address all kinds of of quality issues. 2) CDSCO will hire two international consultancies to one look at CDSCOs’ internal process and another one to look at The Drugs and Cosmetics Act, 1940 and rules to rationalise while removing the redundancies and simplifying the whole regulation.3) Increasing the internal scientific cadre at CDSCO to do internal review of the files, which the stakeholders are not comfortable with. 4) Indian Pharmacopoeia Commission (IPC) to set up the Digital IP.
The Indian regulators has upgraded Schedule M (GMP Practices) of the Drug and Cosmetic Rules, surpassing WHO GMP standards in some areas and will be starting the inspections from coming month.
Views: The quality focus bodes well for domestic formulations players, MNCs and domestic CDMO players as it is likely to bring long awaited consolidation in the industry and reward the players who are adhering to the quality standards.
Impact: Positive