Sikkim Drug License
Sikkim Drug License
The Drugs and Cosmetics Act, 1940, regulates the import, manufacture and distribution and sales of drugs in India. The Act ensures that the drugs and cosmetics sold in the country are safe, effective and are in conformity with the quality standards. Each State in India has its Food and Drug safety administration departments which administer the rules and regulations concerning drug license in accordance with the provisions of the Act. In this article, we look at the procedure for obtaining Sikkim drug license in detail.
What is a Drug?
A ‘Drug’, as specified in the Drugs and Cosmetics Act, 1940, is the holistic classification of medicines for internal or external use of human beings or animals which is utilized in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, encompassing the preparations applied on the human body to repel insects like mosquitoes.
Central Drugs Standard Control Organization (CDSCO)
CDSCO, which comes under the ambit of the Ministry of Health & Family Welfare, is the National Regulatory Authority (NRA) of India. The entity is involved in the uniform implementation of the provisions of the Drugs and Cosmetics Act, 1940 and rules 1945.
Responsibility of CDSCO
- Sanctioning of Drugs.
- Conducting Clinical Trials.
- The framing of Drug standards.
- Controlling the quality of imported Drugs in the country.
- Coordinating the activities of State Drug Control Organizations.
CDSCO and state regulators are collectively responsible for grant of licenses of the specific category of vital Drugs such as blood and blood products, Intravenous (IV) Fluids, Vaccine and Sera.
CDSCO introduced an E-governance system known as Sugam for the online processing of applications, linking of CDSCO HQ with other offices and laboratories, and for maintenance of the database to promote Ease Of Doing Business.
Drugs Cell of Sikkim
The Drugs Cell of Sikkim was created in 1986 for the enforcement of the Drugs and Cosmetics Act, 1940 and Rules, 1945.
The primary functions are
- Grant and renewal of the license for the retail and wholesale trade of medicines (including Homeopathic medication).
- Grant and renewal of licenses for manufacturing of drugs and cosmetics.
- Collection of random samples from the manufacturing premises for examining the standards of medicines.
- Initiation of action against spurious, adulterated, and drugs of poor quality standards.
Documents Required for Establishing a Trade in Retail/Wholesale Sale of Medicines
- Copy of firm registration which is issued by the District Collectorate.
- Copy of the registration of Pharmacist, as the sale, should be supervised by a Registered Pharmacist.
- Copy of ‘house deed’ is required if the applicant owns the premise. In the case of rented property, a ‘No objection certificate’ must be obtained from the owner of the premise.
- Application Form -19, 19 A, 19 B, 19 AA, duly filled up and signed by the applicant.
- Plan document of the premises of trading.
- The documents of purchase of refrigeration and deep freeze units are required.
Workflow of Obtaining Selling License
Renewal of Drug Selling License
- The license can be renewed by submission of Form 20, 21, 20 B, 21 B, 20 A, 21 A, 20 C, 20 D, 20 F, 20 G, 20 BB to the concerned state authorities, with the required fees for renewal.
- The application is examined, and the premises are inspected. On compliance of the mandated conditions, the license is renewed.
Documents Required for Renewal of License
- Copy of cash receipt/ challan for fee payment.
- Photocopy of license or previous renewal certificate.
- Copies of their educational qualification, experience and registration certificates of the competent technical staff / registered persons.