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) […]
Delhi HC bars Natco Pharma from selling cancer drug Olaparib
Source: Economic Times The Delhi High Court has barred Natco Pharma from manufacturing and selling cancer drug Olaparib either under the brand name ‘BRACANAT’ or under other brand names till further orders. “…the defendant (Natco) is in fact exploiting the suit patent by manufacturing and selling Olaparib. It is also admitted that this exploitation has take place in the 19th year of the […]
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, […]
Maker of spurious antibiotics busted in Uttarakhand
Source: CNBCTV18 A joint operation coordinated by the Drug Control Administration (DCA) of Telangana, Commissioner Task Force Hyderabad, and Malakpet Police named Operation JAI, has dismantled an inter-state network involved in the manufacturing and distribution of spurious drugs. The operation uncovered nefarious activities centred around a pharmaceutical factory named Nectar Herbs & Drugs located in […]
Why are pharma MNCs reducing India footprint?
Source: Times Of India Late on Feb 16, Swiss pharma major Novartis made a brief announcement that it had started a “strategic review” of its listed entity, Novartis India Limited, which includes an assessment of its shareholding in the subsidiary. Exactly three months ago, UK biggie AstraZeneca had also announced it was exiting manufacturing in […]
Made-in-HP drug samples fail quality test
Source: Times News Network Kullu: The samples of 14 drugs manufactured in Himachal Pradesh have failed a quality test run by the Central Drugs Standard Control Organisation (CDSCO). In an alert issued for the month of January, the CDSCO has declared these 14 samples of drugs, manufactured in Baddi and Nalagarh in Solan district and Paonta Sahib […]
CDSCO releases regulatory guidelines for sampling of drugs, cosmetics and medical devices
Source: Medical Dialogue New Delhi: In order to streamline and rationalize the sampling procedure of drugs, cosmetics and medical devices and maintaining a centralized monthly database of Not of Standard Quality (NSQ) /Spurious drugs to publish on Central Drugs Standard Control Organisation (CDSCO) website, the apex drug regulator has released regulatory guidelines for sampling of […]
Namita Thapar’s Emcure Pharma Set To Launch IPO
Source: Times of India At a time when Shark Tank India judge Ritesh Agarwal’s OYO is inching closer towards launching its much awaited IPO, it seems that another shark’s company is planning to go public. Namita Thapar, who is the Executive Director (India Business) of Emcure Pharmaceuticals, had said earlier this month at the ET NOW Global Business Summit […]
Exclusive: Govt mulling new PLI scheme for pharma sector
Source: Money Control The government is mulling over introducing a new production-linked incentive (PLI) scheme for the pharmaceutical sector to boost the production of key chemicals critical to the manufacture of active pharmaceutical ingredients (APIs). In doing so, it aims to reduce Indian companies’ dependence on China for such supplies, sources told Moneycontrol. “The entire value chain […]