The Drugs Control Subdivision regulates the manufacture and sales of medications and Cosmetics. The Government has laid down numerous drug laws under which the State Drug Controller deals with the permitting of both manufacturing and sale locations of drugs & cosmetics.
Drugs are specific from other commodities and due to the fact the Government has laid down stringent law. Regulation governing manufacture & sale of drugs are given in the Drugs and Cosmetics Act, 1940 and Rules framed there under. Control is exercised over drugs from the uncooked material during manufacture, sale, and distribution and up to the time it is passed-on to a patient or purchaser by a Pharmacist in retail Pharmacy, Hospital or a Dispensary.
Following are the types of license required in India:
- Manufacturing License– Certificate issued to a business that manufactures drugs inclusive of allopathic/ homeopathy drugs.
- Sale License – License issued for the sale of drugs. It has the following bifurcations:
– Wholesale Drug License
– Retail Drug License
– Restricted Drugs
- Loan License – License issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
- Import License – License issued for the import of drugs.
- Multi-Drug License – License issued to businesses that own pharmacies in multiple states with the same name.
1. Pharmacist/ Competent Individual: The pharmacist must be qualified in the case of a retail business. In case of a wholesale business, the individual must be a graduate with 1-year experience or an undergraduate with 4 years experience.
2. Space Requirement: The other significant requirement is space that is the space of the pharmacy/unit.
– For both wholesale and retail authorization – 15 sq meters.
– In all other cases – 10 square meters.
– The clear height of the sales premises shall be as per the guidelines laid down under the National Building Code of India, 2005.
3. Storage Facility: The other important requirement is storage facility since some drugs require being stored in low temperatures, refrigerators and air conditioners are a must.
- It is compulsory to be owned by all kinds of drugs and cosmetic businesses.
- Every pharmacy business needs to comply with the terms and conditions of the license.
- The drug marketing license can be granted in two premises:
– Commercial premises
– Other premises independent of residence.
- The license should be displayed at the centre of premises.
- It is compulsory to own a drug license in each state-run if you are functioning in two or more states.
- Those who have migrated will need to fill another form.
Following documents are required with application form:
- Constitution of the firm (MOA/AOA)
- Photo ID proof of proprietor/partner/director
- Copy of Property paper (If owned property)
- Copy of Rent agreement (If rented property)
- Site Plan and key plan of the locations
- Refrigerator invoice and details
- Affidavit regarding compliance of MPD 2021 (if premises are located on DDA residential flat/ plot/ building
It might be a little complex procedure to obtain a drug license in India but with the help ASA you don’t have to worry about it.
Some business entity may require different type of drug license based on their business. For this ASA’s team of experienced professionals are here to give you consultancy on it. Our experts who know all the legal procedures will work for around the clock.
You can hire professionals from ASA who will help you in getting the drug license and will also save from all the government hassles.