Revised guidance on quality & safety documents
Source: PharmaBiz The Central Drugs Standard Control Organisation (CDSCO) has come out with a draft of revised guidance document for the industry related to the quality, safety and efficacy documents for Post Approval Changes (PACs) in biological products in order to align the standards with the international guidelines including that of World Health Organisation (WHO) […]
Is Govt. planning to put nutraceuticals under CDSCO?
Source: The Times Of India The government has formed a panel to examine the possibility of bringing nutraceuticals under the ambit of the apex drug regulator CDSCO instead of the food regulator FSSAI to address regulatory challenges and promote consumer safety Presently, the Food Safety and Standards Authority of India (FSSAI) regulates the usage of health supplements and nutraceuticals under the Food Safety and Standards […]
Drugs regulator plans standards overhaul in India
Source: LiveMint New Delhi: With the Indian pharmaceutical industry increasingly coming under the scanner globally, the Central Drugs Standard Control Organisation (CDSCO) is conducting a major exercise for improving the quality, safety and efficacy of biological products. The apex drug regulator has come up with the latest guidelines on biological products such as vaccines, biological, […]
Pharma MSMEs resent new norm
Source: Tribune India The Himachal Drug Manufacturers’ Association (HDMA) has sought relaxation in the 45-day payment norm for industries having a turnover of Rs 100 crore and Rs 50 crore for one year and two years, respectively. The new provision, introduced under Section 43 B of the Income Tax Act, would be implemented from the […]
Pharma stock falls by 7% after USFDA inspection
Source: Tradebrains Share price of an integrated global pharmaceutical company fell by nearly 6.95 percent and closed at Rs. 1,070.45 on Thursday, which is the biggest single-day fall since November 2022. With a market cap of Rs. 62,724 crore, shares of Aurobindo Pharma Ltd. opened at Rs. 1,155.05 on February 1st, compared to its previous close of […]