Standards
The Bureau of Indian Standards (BIS), the National Standards Body of India, and controls all matters concerning Standardization, Certification and Quality. Database of Indian Standards is being developed and is going to be installed very soon and will give title of the standard, its equivalence with foreign standards, ICS and HS Codes and the information about its coverage under certification marks scheme etc. The database being developed as per ISONET Manual. BIS has also accepted the Code of Good Practice for the Preparation, Adoption and Application of Standards. In order to fulfill the resultant obligations BIS publishes detailed Work Programme for each of the 14 Division Councils (under which standards are formulated) once in a year on 1 April.
The Government of India, Ministry of Commerce has designated BIS as the enquiry point under the Agreement on Technical Barriers to Trade of the WTO. According to the Agreement, the Enquiry Point issues notifications on proposed technical regulations and certification systems in India to WTO. Parties in other member countries wishing to make comments on the above notifications can obtain copies of the text from the Enquiry Point.
BIS has recently set standards for packaged water,
Under the Drugs and Cosmetics Act, 1940, standards for most products are cross referenced including Schedule O (Disinfectant Fluids); Schedule S (Cosmetics); Schedule V : (Patented or Proprietary medicines) and so on. As per Rule 124, of the Drugs and Cosmetics Rules 1945, the standard of drugs included in the Indian Pharmacopoeia, shall be the standard as specified in the pharmacopoeia and in the absence of such inclusion, the standard adopted by the manufacturer is considered the applicable standard.
CLG’s regulatory practice straddle a number of industry areas including pharmaceuticals, biotechnology, vaccines, medical devices, food and beverages, wines and spirits. The interdisciplinary Food and Drug Team includes lawyers and technical professionals having considerable experience across virtually all the industry sectors regulated by the food and drug administration. A significant part of the firm’s food and drug law practice is devoted to counseling clients concerning statutory and regulatory requirements. We have assisted our clients in obtaining necessary regulatory licenses and statutory approvals particularly with regard to product approval for marketing and manufacturing and safety issues, Good Clinical Practice requirements, Good Manufacturing Practice Requirements, regulatory strategies and life cycle management, labeling, advertising, import/exports clearances for biological and dual use materials, clinical investigation requirements, product liability, market protections and enforcement issues.
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