Drugs (Sixth Amendment) Rules, 2022

The amendment has provided that in case of disinfectants, the colors referred in IS 4707 (Part I) as amended by Bureau of Indian Standards from time to time shall be permissible to use.

Capped trade margin for medical devices

Trade margin of five medical devices, namely, (i) Pulse Oximeter, (ii) Blood Pressure Monitoring Machine, (iii) Nebulizer, (iv) Digital Thermometer, and (v) Glucometer at capped at 70%.

Department of Pharmaceuticals invites application for Vitamin B1 under the category ‘Other Chemical Synthesis based KSMs/Drug Intermediates/APIs’ under Production Linked Incentive (PLI) scheme for Bulk Drugs.

Under this Scheme, the Eligible Product ‘Vitamin B1’ was categorised under the head‘Fermentation based niche KSMs/ Drug Intermediaries/ APIs’ and applications were invited accordingly. However, representations were received subsequently that the Vitamin B1 can be manufactured through chemical synthesis route also. Therefore, the classification of the Eligible Product: ‘Vitamin B1’ has been changed to ‘Other Chemical Synthesis based KSMs/ Drug Intermediaries/ APIs’.

Schemes for Strengthening Pharmaceuticals Industry with Focus on MSMEs and Clusters

In order to strengthen the supply chain of Pharmaceuticals industry where MSMEs are an integral part, Govt of India shall be incentivizing the intending MSME units going in for acquiring Schedule M certification or WHO GMP Certification through the sub-scheme Pharmaceuticals Industry Technology Upgradation Assistance Scheme (PTUAS)