The Indian government has designated the Central Drugs Standard Control Organisation (CDSCO) as the first point of registration for clinical trials of all drugs and vaccines, a move expected to cut the approval time to three months from 12 months, according to the Economic Times. The cabinet secretary-led panel has...
India to Streamline Regulatory Oversight of Medical Devices
India's Central Drugs Standard Control Organization (CDSCO), the national regulatory authority for drugs and medical devices, is now acting on a report submitted by the Drugs Technical Advisory Board (DTAB) — the country’s highest statutory decision-making body on technical matters related to medicines and medical devices. According to the proposal...
India Simplifies Licensing for Medical Device Manufacturing
Per India's Medical Device Rules, 2017 that came into effect in January this year, new licenses awarded for manufacturing and import of medical devices will not need periodical renewal and will remain valid until they are either suspended, cancelled, or surrendered. The licensee will need to pay a retention fee once every...
India Updates Draft Rules and Fees for Med Devices
After consultations with stakeholders, India's Central Drugs Standard Control Organization (CDSCO), a federal government body, released an updated version of its draft rules for medical devices, including fees payable by the industry. The fees schedule related medical devices is based on 3 categories - A (low risk), B&C (low Moderate...
No more animal testing for cosmetics – India
India on Friday decided to ban animal testing for cosmetics, becoming the first country in South Asia to do so. The Bureau of Indian Standards has now approved the removal of any mention of animal tests from the country's cosmetics standard, according to Humane Society International (HSI). The decision was...