The Drugs and Cosmetics Acts, 1940 and The Drugs and Cosmetics Rules, 1945 are the two laws governing the Import, sales, manufacture and distribution of Drugs in India. Any product falling under the category of Drugs or Medical related devices needs to be registered before getting imported to India. It is also required to register the manufacturing site for the purpose of importing to India. If the drug which is to be Imported falls under the category of New drug, then before the submission of the application of registration and Import of that drug, it is important to get New drug approval for the product. The CDSCO provides license and registration certificates for the Import, export, manufacturing, sales, distribution etc., of the drugs.
Need for Drugs
Medicines and Medicinal products and devices are demanded throughout the world. There are some products that are manufactured all over the world, whilst there are certain products that are manufactured only in a particular country, region or by a particular manufacturer. Due to this, the drugs are imported from one place to another for a variety of uses. All the drugs must be registered before importing them to India. India holds the third largest place in the world in the pharmaceutical Industry. All the activities related to registration, licensing, Import, export etc., of drugs are governed by the Drugs and Cosmetics Acts, 1940 and Drugs and Cosmetics Rules, 1945, under CDSCO in India.
All the products falling under the definition of Drugs needs to be registered first under CDSCO, along with registration of the Manufacturing Site. The Indian medical Industry has been growing at a huge rate. With the rise in population, there is a huge rise in health problems. New diseases, pandemics etc., are being introduced every now and then. Due to this, there has been a huge demand for medicines and medicine-related products in India. As the growth in demand persists, there still stands a problem of the basic infrastructure and resources to combat the problems and ailments in the pharmaceutical sector. This Industry is, however, the most profitable Industry for the purpose of Investment globally. There is a huge demand and profit in setting up pf Pharmacy shops, Hospitals, Manufacturing sites, etc.
Role of CDSCO to Import Registered Drugs in India
CDSCO is also known as Central Drug Standard Control Organisation. It works under the Ministry of Health and Family Welfare, Governed by the Government of India. It is the National Drug Regulatory Authority of India. CDSCO is authorized to maintain and regulate all the procedures related to the Import, Export, Registration, manufacturing, and Licensing of Drugs, Medicines, Medical Devices, IVDs and Medical related products in India. CDSCO is responsible for Import Registered Drugs in India. The application for obtaining an Import or Registration License has to be submitted to the Drug Controller General or DGI at CDSCO. For the purpose of Import Registered Drugs in India of bulk quantity, it is also required for a Manufacturing site and product to be registered with CDSCO.
Eligibility to Import Registered Drugs in India
The following are eligible to Import registered drugs in India:
- The Foreign manufacturers who have obtained a license for the sale or distribution of drugs in India
- Local authorized Agent of the foreign manufacturers who has obtained manufacturing or sales license
Documents required to Import Registered Drugs in India
The following documents are required to Import registered Drugs in India:
- Covering Letter
- Power of Attorney (original)
- Application Form
- Copy of Import permission
- Copy of wholesale/manufacturing license of the Indian Agent
- Authorization letter
- Schedule D (I) and Undertaking are duly signed, sealed and stamped by the Authorized person of the manufacturer or by his Indian Agent.
- Schedule D (II) and Undertaking are duly signed, sealed and stamped by the Authorized person of the manufacturer or by his Indian Agent.
- Free sale certificate
- Manufacturing License & Market authorization Certificate
- Establishment License
- Inspection or Audit Report
- An Undertaking from the proprietor of the firm (in case of proprietorship firm)
- An Undertaking from the Board of Directors (BoDs) (in case of a Private Limited Company)
Procedure to Obtain a License to Import Registered Drugs in India
In order to obtain a license to Import Registered Drugs in India, the manufacturer or his Agent first needs to acquire a registration certificate, followed by the Import License. The applicant is required to apply for the Registration Certificate and Import License at CDSCO.
Following is the procedure to obtain a license to Import Registered Drugs in India-
- There is an Application form as Form-40 that needs to be filled and submitted to the licensing authority, by the foreign manufacturer or by his Authorized Agent in India, along with some undertakings mentioned in Schedule D (I) and D (II), which has to be duly signed by or on behalf of the manufacturer.
- Import registration certificate is then granted by CDSCO as Form-41. The Certificate of Registration is valid for a period of three years.
- After receiving the registration certificate, an application for an Import license should be submitted to the Licensing Authority (LA) in Form 8 for drugs excluding Schedule X and in Form 8-A for drugs in Schedule X by the manufacturer or his Authorized Agent. The form is to be accompanied by an application fee of 1000/- for one drug, along with an additional fee of 100/- for each additional drug, along with an undertaking in Form-9 duly signed by the manufacturer or on his behalf.
- The Import License is then obtained as Form-10 from the CDSCO office. The license remains valid for the period of three years or until the period of expiry of the registration certificate.
As the drug and Medicine industry is rapidly growing in India, there is a strict need to regulate the actions and working of the Industry in order to avoid low quality and unsafe goods from reaching the common crowd. The government maintains strict entry rules to restrict the entry of new entrepreneurs into the drug business and to maintain the quality and standard of the drug and medicine industry in India. Thus the government has made it mandatory for manufacturers or Importers to obtain a license to Import Registered Drugs in India in order to avoid low-quality products which could affect the crowd in any possible way. License to Import Registered Drugs is a great way to put a barrier on the new competition and cut the illicit practices in the medical Industry by foreign manufacturers, and safeguard the health and Lives of people.
Read our Article:CDSCO Certificate for Drugs Import to India: An Overview