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Drug License in India
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Drug License in India
Drug and cosmetic industry serve the interest of a larger community, an Act to regulate its manufacture, import, sale, and distribution was passed in the year 1940. The drug license rules under the Drug and Cosmetic Act, 1940 are as follows:
- The person who wishes to acquire a drug license must have at least four years of practical experience in the distribution of drugs.
- A licensee can only manufacture any drug under the personal supervision of a registered pharmacist.
- Further, the retailer of the drug must keep a record in the register at the time of drug supply.
- The licensee ought not to sell or stock any drug after its expiry date.
- Also, the drugs can be sold to a minor (below 18 years).
- The medicine in a retail shop to cure animals should have a tag of “Not for human use, for treatment of animals only.”
Eligibility for obtaining Drug License
- Drug and Cosmetic Act has set a long list of requirements that every medical aspirant has to fulfil to procure a drug license. Here are the basic needs as per drug rules:
- The carpet area of a drugstore should be 10 Sq. and meter for retail or wholesale outlets. Besides, you need to have 15 square meters area for combined wholesale and retail.
- Any drugstore or pharmacy must have an air conditioner, sound ventilation system, and refrigerator.
- According to the act, a person can only conduct the drug business in the presence of any of these persons:
- Any Registered Pharmacist under State Pharmacy Council.
- A graduate with a minimum of 1-year experience in drugs sales and marketing in a reputed pharmacy.
- An individual with four years of experience in pharma marketing and has passed S.S.L.C.
- Even a person approved by the department of drug control is eligible.
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Conclusion of Drug License in India ?
- Drugs and medicines are a necessity and essential products. Understanding its importance the government has laid down a strict application process for obtain a drug license. Starting a wholesale drug business in India is not very complex but yet a person needs to prepare for it. All the formalities are required to be completed in the process of issuing drug license. This ensures that the drug wholesalers comply with all the provisions. To apply for wholesale drug license in India the applicant is required to apply in accordance with the rules and regulation of the Drugs and Cosmetics Act, 1940. The provisions ensure that the drug business is undertaken and performed by a qualified and competent person.
- Since the safety of the people is the most important priority, the government ensures that the drugs do not risk the lives of the people. The Central Drug Control Organization (CDSCO) is the regulatory body for pharmaceuticals and medical devices. CDSCO is responsible for the laying down the standards for drugs and coordinate with the activities of the State Drug Control Organization (SDCO) by providing expert advice to bring about uniformity in the enforcement of the provisions of the Drugs and Cosmetics Act.
Steps For Getting Drug License
- One can file the Drug License application directly with the government. The process is long and requires 60 days to get completed :
- Step 1 : Fill the application.
- Step 2: Visit by the Drug Inspector.
- Step 3 : Issue of the Drug License.
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