For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall include members who are Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 172 of 248 knowledgeable about pediatric, ethical, clinical and psychosocial issues. (iii) Pregnant or nursing women: (a) Pregnant or nursing women shall be included in cl ...

Studies in special populations: The clinical investigation data of the medical device is required to be submitted to support the claim sought to be made for use of medical device in children, pregnant women, nursing women, elderly patients with renal or other organ system failure as given below:— (i) Geriatrics: Geriatrics patients can be included in pivotal study (and in pilot study at the sponso ...

THE BUREAU OF INDIAN STANDARD (BIS) Is a national standards body in India that operates under the Ministry of Consumer Affairs, Food, and Public Distribution. It plays a vital role in ensuring the quality and safety of products and services. Its main function is to formulates and promote standards to ensure the quality and reliability of products, covering a wide range of industries and sectors. I ...

THE FOOD SAFETY and STANDARD AUTHORITY OF INDIA (FSSAI) Plays a pivotal role in ensuring food safety and hygiene standards across the country. Some of the key functions of FSSAI include laying down rules for food safety and quality standards to ensure the production, distribution, and consumption of safe and wholesome food. Accredited Consultants Pvt Ltd (ACPL) serves as a regulatory consultant, ...