Narcotic drugs and psychotropic substances can be imported and exported subject to the following restrictions:
- import and export of narcotic drugs and psychotropic substances listed in Schedule I to the NDPS Rules is prohibited.
- Import of opium, concentrate of poppy straw, and morphine, codeine, thebaine and their salts is prohibited except by the Government Opium Factory. However, certain manufacturers who require these substances only for export, and importers of samples of these substances up to 1 kg in a year can import the substances after following the due procedure, provided they are notified by the Government to do so.
- Export of some psychotropic substances is not permitted to specific countries. These substances and the countries to which each substance cannot be exported are listed in Schedule II of the NDPS Rules, 1985.
- To import any narcotic drug or psychotropic substance, one should apply for and obtain an import certificate from the Narcotics Commissioner for each consignment.
- To export any narcotic drug or psychotropic substance, one should apply for and obtain an export authorization from the Narcotics Commissioner for each consignment.
Meaning of Drugs
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.
Purpose of Drug Licence
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. In addition to a drug license, they must also obtain a trade license and a shop and establishment registration.
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.
Drug Controlling Authority or Regulatory Authority
- State Drugs Standard Control Organisation (SDSCO) – Issues licenses for the sales, distribution, and manufacture of drugs regulated by the state authorities.
- Central Drugs Standard Control Organisation (CDSCO) – Responsible for approving and issuing licenses for the newly made drugs and clinical trials of drugs. It also controls the quality of the imported drugs and coordinates with the SDSCO.
- State Drug Controlling Authority with approval by the Central License Approving Authority – Issues licenses for establishing blood banks and their components and products like Vaccines, Sera, etc.
- Department of Ayush – Issues licenses for ayurvedic, Unani, Siddha, homoeopathic and herbal products for cosmetic and medical use.
Types of Drug License
- Manufacturing License– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
- Sale License – License issued for the sale of drugs. It has the following bifurcations: – Wholesale Drug License – Retail Drug License
- Wholesale License – A drug wholesaler must obtain a wholesale licence. Wholesale means the sale of the drug to a person/retailer to further sell it.
- Retail License – A retail license is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc need this license.
- Loan License – License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee to manufacture drugs.
- Import License – License issued to any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India.
- Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.
Application for a 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.
Upload documents- 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.
FAQs
Who issues the No Objection Certificate (NOC) for importing narcotics drugs?
The No Objection Certificate (NOC) for importing narcotics drugs is issued by the Narcotics Commissioner’s Office, which operates under the Central Bureau of Narcotics (CBN), Ministry of Finance, Government of India.
What is the certificate required for importing narcotics drugs into India?
To import narcotics drugs into India, a No Objection Certificate (NOC) from the Narcotics Commissioner’s Office under the Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, is typically required. This certificate is essential to ensure compliance with legal and regulatory requirements.
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