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The Drugs and Cosmetics Cell of the Health Care, Human Services and Family Welfare Department is primarily responsible for the enforcement of the provisions under the Drugs and Cosmetics Act, 1940 and Rules, 1945 in the state of SIKKIM .The said ACT was enforced in the State during the year 1985.

The Cell is also responsible for the enforcement of the enforcement of the Sikkim .Anti Drugs Act, 2006 and Rules, 2007 which includes organistion of various awareness camps in the State regaardind the drug abuse and also the legal aspect of the Act. The following are the activities, staff pattern and the achievevment of the Cell since the implementation of the State.

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.

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.

Definitions of Drugs & Cosmetics

“Drug” includes— All medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human Beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes.

“Cosmetic” means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applicated to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic.

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.