Overview
Drug License Registration is a mandatory requirement under the Drugs and Cosmetics Act, 1940 for any business involved in manufacturing, distributing, selling, importing or exporting drugs and pharmaceutical products in India. The main objective of this Act is to ensure that drugs sold in the country meet prescribed standards of quality, safety and efficacy. It is regulated by the Central Drugs Standard Control Organization (CDSCO) at the national level and the State Drug Control Authorities at the state level.
Any business engaged in manufacturing, distribution, retail sale, wholesale trading or import of drugs must obtain a drug license before starting operations. Drug licenses are broadly categorized into Manufacturing License for production units and Retail or Wholesale License for selling and distributing drugs. Additionally, specific licenses may be required for Ayurvedic, Homeopathic or Unani medicines, apart from modern pharmaceutical products.
Drug licenses are essential to operate legally and ensure consumer safety. Non- compliance can result in severe penalties, closure of business and legal action. The licensing system also helps businesses build credibility, access government tenders, and comply with regulatory inspections. It ensures that all pharmaceutical products in the market are safe, labelled correctly and stored under proper conditions.
BizGlobal Professional Services provides end-to-end support for obtaining Drug Licenses. We help businesses identify the correct category of license, prepare documentation, submit applications to the relevant State Drug Control Authority or CDSCO, coordinate inspections, and ensure approval. Our experts guide clients through compliance requirements, renewals and amendments, helping pharmaceutical businesses focus on growth while we manage regulatory processes efficiently.
