About Us

What We Do for You?

TPRAC is a regulatory affairs consulting and intelligence team is comprised of senior pharmaceutical regulatory experts with extensive experience in approval of Licensing activities and ensures compliances in various legal and regulatory aspects of Drugs & Cosmetics, FSSAI, Medical Devices, Explosive Licence, Narcotics & psychotropic substances, Biological Products, New drug approvals, FDA Approvals, NPPA (Price approval), preparation of registration strategies and successful registration of products with regulatory authorities.

Services in Indian Regulations & Guidelines: Drugs

Drug license is a permission granted by the competent authority under Drugs and Cosmetic Act, 1940 to carry out a business concerning drugs/medicines or cosmetics. In other words, no person can start or continue a business dealing with drugs or cosmetics in India, unless an appropriate license is obtained for the conduct of such activity. Under the purview of Drugs and Cosmetics Act, 1940 all types of drugs or cosmetics business is covered including Allopathic, Homeopathic, Ayurvedic or Unani drugs. To maintain the quality of drugs and cosmetics is the responsibility of all persons dealing with it. If any person consuming or using a drug or cosmetic suffers any harm from the negligence on the part of the manufacturer or seller the same is an offence, which is triable as an offence of grievous hurt under IPC.

Pharma Regulatory Organizations & Acts - India These are the bodies that perform various functions for Drugs & Cosmetic regulations in India. We offer consultation and execution of all formalities in order to clear compliance and regulations. This is to create market authorization for manufacturers, importers & distributors in India.