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, […]
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 […]
Licenses of 64 pharma companies cancelled after govt crackdown

Source: The Hindu Businessline Indian authorities, over a one-year-period, have cancelled licenses of 64 pharma companies, while 17 drug testing laboratories have been asked to shut down for non-compliance with ‘good manufacturing practices’ and other “continued” procedural lapses. As per the World Health Organisation (WHO), ‘good manufacturing practices’ refer to that aspect of quality assurance […]
250 ‘actions’ initiated after inspection of 275 drug firms.

Source: Telegraph India India’s drug regulatory authorities have initiated more than 250 “actions” after inspections of the premises of 275 drugmakers by central and state authorities, the Union health ministry told Parliament on Friday. It is not clear from the answer how many companies among the 275 inspected received multiple notices or actions. The health […]
Regulator Will Only Accept Soft Copies for Approvals & Licenses

Source: News18 Only emails, pen drives or Google Drive – the country’s apex drug regulatory agency will stop accepting paper-based documentation for granting approvals and manufacturing licenses for drugs, devices and vaccines, News18 has learnt. To promote ‘Digital India’, the Central Drugs Standard Control Organisation (CDSCO) has asked its offices across India to accept “only […]
3 commonly used pain, cough and cold medicines under scanner in India

Source: Deccan Herald The Central Drug Regulatory Authority (CDSCO) has asked companies manufacturing two commonly used cold medicines and one painkiller drug available in fixed-dose combinations (FDC refers to combining two or more drugs in a fixed ratio to develop a single dosage form), to conduct trials ensuring safety and efficacy, the Times of India reported. […]
40 drugs made in Himachal Pradesh fail CDSCO quality test

Source: TNN Kullu: The samples of as many as 40 drugs, manufactured in Himachal Pradesh, have failed the quality test run by the Central Drugs Standard Control Organisation (CDSCO), a central drug regulatory body that approves and bans drugs and also conducts monthly clinical trials to test the quality of drugs. According to the drug alert […]