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According to India's Drug and Cosmetics Act of 1940, every manufacturer, distributor, seller or importer of drug or cosmetic products must obtain a drug license. It is issued by the State Drug Control Organization or the Central Drugs Standard Control Organization CDSCO, and its role is to ensure that good, quality and standard drugs and cosmetics are available in the market. They are classified under various categories depending on the type of business, such as manufacturing, wholesale and retail traders. This requires submitting several documents and evidence, including ownership or leasing of the premises, qualification of the responsible person, forms number 19 or 20 and all the other relevant forms. Noncompliance with the expected standards is liable for fines and suspension or revocation of licenses. This licensing system contributes towards delivering such a society since it maintains the population's health by regulating the supply of pharmaceutical products.
A brief explanation of the definition under section 3(b) of the Drugs and Cosmetics Act,1940: Drugs encompasses all medicines and substances intended for humans or animals for internal or external use to diagnose, cure, alleviate, treat, or prevent diseases, and includes insecticides. This definition also covers items that influence bodily functions and substances that eliminate diseases caused by pets or insects, as may be specified by the Central Government. It also covers any materials used in making the drug, including empty gelatin capsules and medical devices, whether for diagnostic or therapeutic use, which the Central Government shall notify in consultation with the Board.
A drug license in India is necessary to control the availability of medicines and the use of drugs as per the anticipated usage to save people from adverse reactions. Every person in the business of dealing in drugs, whether as a chemist, wholesaler, retailer, manufacturer, seller, dealer, or importer, is required to get a drug license under the Drugs and Cosmetics Act 1940, a trade license, and shop and establishment registration where necessary. This applies to general drugs, cosmetic, herbal, ayurvedic, Siddha and Unani products, etc. The drug standards are set by the Act and its Rules, 1945, and they provide strict quality checks from the inputs to the outputs and even the final sales. The government supervises the production, distribution system, imports, exports and sale of retail and certain ethical drugs such as Schedule H and X. Through the issuance of licenses, the drug control authority is in a position to enforce these regulations and protect the public's health.
a) Ownership documents or rental/lease agreements of the premises.
b) Blueprint or layout of the premises showing dimensions and facilities.
a) Partnership deed (for partnerships) or Memorandum of Association (MoA) and Articles of Association (AoA) (for companies).
b) Proprietorship declaration (for sole proprietors).
a) PAN card of the applicant or business entity.
b) Address proof such as an Aadhaar card, voter ID, or passport.
c) Recent passport-sized photographs of the applicant.
a) Educational certificates of the applicant or pharmacist (e.g., Diploma or Degree in Pharmacy).
b) Registration certificate of the pharmacist from the State Pharmacy Council.
c) Experience certificate (if applicable).
a) GST registration certificate.
b) Bank account details.
a) An appointment letter from the pharmacist or qualified person, if applicable.
b) Storage arrangement details (e.g., cold storage facilities for temperature-sensitive drugs).
c) List of products or medicines to be manufactured or sold.
a) Application form (Form 19, 19A, 20, 20B, etc., depending on the license type).
b) Affidavit for compliance with the Drugs and Cosmetics Act, 1940, and Rules, 1945.
c) Trade license from the local authority (if applicable).
d) Shop and Establishment Act registration.
a) No Objection Certificate (NOC) from local authorities for particular premises.
b) Manufacturing license applicants must provide plant master files, GMP certification, and technical staff details.
c) Import/export licenses require product registration with the Central Drugs Standard Control Organization (CDSCO).
a) Authorization letter (if submitted by an authorized representative).
b) Declaration forms for specific drug categories, such as Schedule H or X drugs.
The applicant needs to go to the particular official website of the concerned drug control authority, which could be either SDSCO CDSCO or Ayush, in accordance with the type of license sought because each one of the authorities issues different sorts of drug licenses.
Any license requires the appropriate documents to obtain it. While documentation may be time-consuming and may seem redundant, it is helpful in reducing difficulties with the licensing procedure when done right, and its use improves the likelihood of being granted a successful license. The list of documents required depends on the type of business applying for a permit and the type of sale involved, more specifically, wholesale or retail drug sales and other business activities involved.
According to the abovementioned rules and regulations, applicants need to apply for a drug license to the Drug Controlling Authority of the respective state where they want to begin their business. As is valid with all other licenses, each type has its own form to which it can be applied. There is no common license required for operation in several states; therefore, license applications have to be made in every state from which they operate.
An appointed drug inspector shall inspect the business establishment in which a drug license application is to be filed. This inspection requires confirmation of the details filled in the application and physical dimensions of the spaces, as well as compliance with the zoning ordinances, such as if the property is zoned commercially or mixed-use.
The Drug Inspector will evaluate the application and other supporting documents in light of findings from the site inspection. If, however, the inspector requires any clarification, the applicant has to provide it within three days. If there is a poor response to any of the questions, their application will not be approved.
Upon completion of a comprehensive verification process and provided that all requirements are satisfied, the Drug Control Department will issue the Drug License.
The issued license remains valid for a duration of five years and can be renewed by submitting the necessary documentation. After this, the authority will extend the license for a specified period.
The main types of drug licenses in India are:
Key eligibility criteria for a retail drug license include:
