Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of any government. But the right to manufacture and sell drugs and medicines has to be given cautiously. Hence the government has stringent rules for granting licenses for the manufacturing and selling of drugs and medicine. The Act that governs the end to end process from manufacture to the sale of drugs in India is the Drugs and Cosmetics Act, 1940.
Section 3(b) of the Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules. The definition was amended in 1964, to include Ayurvedic and Unani Drugs.
The access to medicines and drugs must be restricted and regulated to ensure that such goods are not abused or misused by individuals. Thus, all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers and importers of drugs, cosmetics, ayurvedic, Siddha and Unani drugs have to mandatorily obtain drug license under the Drugs and Cosmetics Act, 1940.
The purpose of the drug license is to grant permission to allow enterprises or individuals to engage in businesses related to drugs and cosmetics. No enterprise or individual can operate a business dealing in drugs, medicines or cosmetics without obtaining a drug license in India.
The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, help the government regulate and monitor the quality of drugs sold in India. The government exercises control over drugs from the raw material stage during manufacture, sale, distribution and till it is sold on to a patient or consumer by a pharmacist in a retail pharmacy, hospital or dispensary.
The government also exercises control in the aspects related to import and export of medicines, sale of the drug to a minor, consumption of schedule H & X drugs, etc., that requires thorough monitoring and cautious execution. The drug license is granted by the drug controlling authority under the Drugs and Cosmetics Act, 1940.
Looking at the definition of “drug”, the pharmaceutical business in India requires the following types of licenses:
The drug controlling authority as known as the drugs controller specified under the Drugs and Cosmetic Act is responsible to issue different drug licences. The drug controlling authorities (licensing authorities) are as follows:
The drug controlling authority or the regulatory authority is responsible for issuing the drug license. The applicant must apply to the respective drug controlling authority based on the license he/she requires as each drug controlling authority is responsible to issue different licenses (as stated above). The following is the process for obtaining the drug license:
Visit the respective drug controlling authority website
The applicant must visit the respective drug controlling authority (SDSCO, CDSCO or Ayush) depending on the type of license he/she is applying for since each drug controlling authority is responsible for the issue of different types of drug licenses.
Filing of application
The applicant must file the drug license application online on the respective drug controlling authority website. The applicant must fill all the details asked in the application form.
After filling in the details on the application form, the next step is to upload the documents and submit the form along with the applicable fees. The applicant must keep all the documents updated before filing the application.
Visit by drug inspector
After receiving the application form, the drug Inspector will personally visit the company premises, shop or the drugstore for the verification of documents and correctness of facts stated in the application.
Grant of the drug license
After inspection and verification by the drug inspector, the drugs controller will issue the drug license.
The documents essential for obtaining a sale license are:
|Sr. No||Form No||Purpose|
|1||Form 19||Application for grant or renewal of a license to sell, stock, exhibit or offer for sale, or distribute drugs apart from those specified in Schedule X.|
|2||Form 19A||Application for granting or renewing a restricted license to sell, stock, exhibit or offer for sale, or distribute drugs by retail via dealers who don’t engage the service of a registered pharmacist.|
|3||Form 19B||Application for license to sell, stock or exhibit or offer for sale, or distribute Homoeopathic Medicines.|
|4||Form 19C||Application for grant or renewal of a [license to sell, stock, exhibit or offer for sale, or distribute] drugs specified in Schedule X.|
|5||Form 20||Application for licence to sell, stock or exhibit or offer for sale, or distribute drugs by retail other than those specified in [Schedules C, C(1) and X].|
|6||Form 20A||Application for restricted licence to sell, stock or exhibit or offer for sale, or distribute] drugs by retail other than those specified in [Schedules C, C (1) and X] for dealers who do not engage the services of a registered pharmacist.|
|7||Form 20B||Application for licence to sell, stock or exhibit or offer for sale, or distribute by wholesale, drugs other than those specified in [Schedules C, C(I) and X].|
|8||Form 20C||Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by retail.|
|9||Form 20D||Application for licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines by wholesale.|
|10||Form 20E||Application for certificate of renewal of Licence to sell, stock or exhibit or offer for sale, or distribute Homoeopathic medicines.|
|11||Form 20F||Application for licence to sell, stock or exhibit for sale or distribute by retail drugs specified in Schedule X.|
|12||Form 20G||Application for licence to sell, stock or exhibit or offer for sale, or distribute by wholesale drugs specified in Schedule X.|
|13||Form 21C||Application for certificate of renewal of licence to sell, stock or exhibit or offer for sale, or distribute drugs.|
|14||Form 24A||Application for either the grant of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified in Schedule C, C (1) and X.|
|15||Form 24B||Application for grant or renewal of a licensee to repack for sale or distribution of drugs, being drugs other than those specified in Schedule C and C (1) excluding those specified in Schedule X.|
|16||Form 24C||Application for the grant or renewal of a license to manufacture for sale [or for distribution] of Homoeopathic medicines or a license to manufacture potentized preparations from back potencies by licensees holding a license in Form 20-C|
|17||Form 24D||Application for the grant / renewal of a licence to manufacture for sale of Ayurvedic/ Siddha or Unani drugs|
|18||Form 24E||Application for grant or renewal of a loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani Drugs|
|19||Form 24F||Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule X and not specified in Schedule C and C(1).|
|20||Form 27||Application for grant or renewal of a license to manufacture for sale or for distribution of drugs specified in Schedule C and C (1) excluding those specified in part XB and Schedule X|
All types of drugs or cosmetics businesses that fall under the Drugs and Cosmetics Act, 1940, are required to obtain a drug license before starting/establishing a drug or cosmetics business. The Drugs and Cosmetics Act covers all drugs businesses, including allopathic, homoeopathic, ayurvedic, Siddha or Unani drugs.
The drugs included under the Drugs and Cosmetics Act are as follows:
Yes. The drug license is also known as a pharmaceutical license. A drug license is required for all businesses involved in distributing pharmaceutical and medicines supplements.
Yes. When a drug business has an operating unit in two or more states, it has to obtain a drug license separately for each state in which it carries the business. The drug license registration is location-specific. Thus, if the drugs are sold or stocked for sale and distribution at more than one place, the application should be made to every state, and a license will be issued regarding each place except for migrant vendors.
A drug licence is valid for five years unless cancelled and suspended by the drug department. It can be renewed before its expiration period by logging into the respective drug controlling website, entering the drug licence number, filling up the renewal application and submitting the document along with the fee for the issue of renewal of the drug license. The drugs controller will issue a renewed drug license.
When there is a change in premises, the drug license for the old premises has to be surrendered, and the drug business owner has to apply for a new licence for the new premises.
Yes, the importers of a drug(s) must obtain both an import license and a wholesale licence to sell imported drugs within India.
The qualification or eligibility of a competent person for retail and wholesale drug license, technical staff of a company dealing in drug or pharmacist are as follows:
A Food and Drug Administration (FDA) license is a license obtained under the Federal Food and Drugs Act. The Food, Drug and Cosmetic Administration (FDA), established in 1906, is a government agency under the Federal Food, Drugs and Cosmetic Act for consumer protection. The FDA license or certification is mandatory for placing food, drug, cosmetics and medical products in the USA.
The following is the procedure to get a drug license in India:
The registration on the CDSCO portal is entirely online. The steps for obtaining registration under the CDSCO portal are as follows:
Click here for more information on CDSCO Online Registration.
The application process for applying for a wholesale license is as follows:
Drug license verification can be done online through the respective state’s drug authority website. You need to enter the unique drug license number to verify the details of the drug license on the website.
The following persons can apply for a drug license in India:
The application fees for obtaining a license vary from Rs.1,500 to 500 depending on the type of application. However, there may be additional charges that the applicant needs to pay for obtaining lab tests, tests or analysis by the Central Drugs Laboratories or State Drugs Laboratories or test or analysis by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) or the government analyst for obtaining the license. The Drugs and Cosmetics Rules, 1945 prescribes the fees for every license application and different tests for different products.
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