Drug & Cosmetic License (CDSCO)

CDSCO (Central Drugs Standard Control Organisation), headed by the DCGI, issues import licenses for drugs and cosmetics under Form 10 and 43 respectively, grants approval for new drugs and clinical trials, certifies medical devices, and sets national standards. State Drug Control Authorities (SDCAs) issue manufacturing licenses (Form 25 for formulations, Form 28 for bulk drugs, Form 32 for cosmetics) and retail or wholesale distribution licenses (Forms 20, 20-B, 21, 21-B). Most businesses manufacturing or distributing in India deal primarily with the State Drugs Controller, while importers must engage with both CDSCO and the state authority.

Schedule M of the Drugs and Cosmetics Rules 1945 prescribes the Good Manufacturing Practices (GMP) that all licensed drug manufacturers must follow. It sets minimum standards for building and premises (minimum floor areas, air handling, water systems), equipment, sanitation, quality control laboratories, documentation, and personnel qualifications. In 2023 the Government of India issued revised Schedule M requirements that align Indian standards with WHO GMP norms. A manufacturing license will not be granted until a Drug Inspector has conducted an inspection and confirmed that the premises and processes comply with the applicable Schedule M requirements. Non-compliance after licensing can result in suspension or cancellation.

Schedule M prescribes different qualification requirements depending on the category of drugs to be manufactured. For allopathic formulations the competent technical staff must hold a degree in pharmacy (B.Pharm), medicine (MBBS), science with chemistry or microbiology as a major subject, or an equivalent qualification, along with prescribed experience in drug manufacturing. For bulk drugs (APIs), a degree in pharmacy, chemical technology, or science with chemistry, plus experience, is required. The individual must be employed full-time at the manufacturing site and must not simultaneously be the qualified person for any other manufacturing license. Their credentials must be verified and supported by notarised copies of degree certificates during the inspection.

Yes, if the product is classified as an Ayurvedic, Unani, or Siddha (ASU) drug under Chapter IV-A of the Drugs and Cosmetics Act 1940. Products marketed with therapeutic or preventive claims are regulated as drugs regardless of whether they contain herbal or natural ingredients. A manufacturing license from the State Drug Authority under the ASU rules is required for manufacturers, and wholesale and retail distribution licenses are required for distributors and retailers. Products sold purely as food supplements without any therapeutic claims may instead fall under the Food Safety and Standards Authority of India (FSSAI) regime, but any therapeutic claim automatically triggers the Drugs and Cosmetics Act classification.

Cosmetics imported into India require an import license under Form 43 issued by CDSCO. The application is filed on the SUGAM portal along with product details, the foreign manufacturer's GMP certificate, the Certificate of Analysis, and the formula or ingredient list. Since the Cosmetics Rules 2020 came into force, all imported cosmetics must comply with labelling requirements including the batch number, date of manufacture, best-before date, full ingredient list in INCI nomenclature, and the name and address of the Indian importer. Prohibited and restricted ingredients prescribed in the Second Schedule to the Cosmetics Rules must be checked before import. The import license is product-specific and must be obtained for each distinct cosmetic product.

Drug manufacturing licenses issued under Form 25 (allopathic formulations) are typically valid for five years from the date of issue and require renewal before expiry by filing Form 26 along with the renewal fee. Wholesale and retail drug licenses (Forms 20, 20-B, 21, 21-B) are generally valid for one year or five years depending on the state's rules and are renewed by filing the prescribed renewal application. Some state authorities issue licenses on a perpetual basis subject to annual renewal fees. Operating on an expired license, even during a pending renewal application, is an offence under the Act and should be avoided by filing the renewal application at least 60 days before expiry.

Adding a new product to an existing manufacturing license generally requires the manufacturer to apply to the State Drugs Controller for an amendment or endorsement of the existing license to include the new product. For most allopathic formulations, the new product must be notified and the license amended before manufacturing commences. For products that fall within the same pharmacopoeial category already covered by the license, a simpler endorsement procedure may apply. New drugs, as defined under the New Drugs and Clinical Trials Rules 2019, require separate approval from CDSCO before they can be manufactured under any license. The specific procedure depends on whether the product is a new drug, an already approved drug in a new dosage form, or a new combination.

A licensed retail chemist must maintain a Prescription Register recording the details of each dispensed Schedule H and H1 drug including the date, name and address of patient, prescribing doctor's name and registration number, drug name, quantity dispensed, and batch number. For Schedule X (habit-forming) drugs, a separate register with purchase and sale entries must be maintained and submitted to the Drug Inspector periodically. Invoices for all purchases and sales must be retained for a minimum of three years. The license certificate must be displayed prominently in the shop. A retail pharmacy must have a registered pharmacist present during all hours of operation.

Dispensing a Schedule H drug (which includes antibiotics, anti-infectives, hormones, and many other categories) without a valid prescription is an offence under Rule 65 of the Drugs and Cosmetics Rules 1945. The first offence attracts cancellation or suspension of the retail drug license and a fine. Repeated offences result in criminal prosecution under Section 27 of the Act with imprisonment of up to one year and a fine. Beyond personal liability, the licensed pharmacist present at the time of sale is also individually liable as the competent person responsible for the pharmacy's compliance. Drug Inspectors frequently conduct test purchase operations to detect over-the-counter sale of scheduled drugs.