How to get Drugs Manufacturing & Sale License?

how to get drugs manufacturing license


The issue of a license is mandatory to run any type of drugs business. Manufacturers, retailers and wholesalers must get a drug license and follow the rules & regulations laid down by the Government of India. If any individual or a business entity is found engaged in manufacturing or distribution of drugs without a valid license, the same is liable for strict legal action. 
 The Drugs and Cosmetics Act, 1940 contains rules and regulations regarding the manufacture, import and distribution of drugs in India. The Act puts out guidelines for drugs that are manufactured in India and ensures that these are safe to use and meet quality standards.
Before we look into procedures to get a drugs manufacturing or trading license, let us understand the meaning of drugs as defined in the Drugs and Cosmetics Act, 1940.


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Definition of ‘drugs’ in the Drugs and Cosmetic Act,1940
The definition of “drugs” has been mentioned in section 3(b) of the Drugs and Cosmetics Act, 1940. According to this section, the term “drugs” include all medicines, substances and devices which humans and animals use for the internal or external purpose to diagnose, treat, prevent or mitigate any disease or disorder; including preparations applied to the human body to repel insects like mosquitoes. Moreover, the definition also contains empty gelatin capsules and other substances used as components of drugs. 

Why drug license is mandatory?
Any firm or company involved in the drugs and cosmetic businesses must get a license to operate their business and adhere to the guidelines mentioned in the Drugs and Cosmetics Act, 1940.  The drug license has been made mandatory to ensure equal access, and to monitor the regulation of drugs to safeguard them from getting misused. 

In fact, the government has made strict rules to follow for the manufacturing and selling of drugs in India. The government also monitors the quality standard of drugs manufactured by the enterprises or firms. The drugs license is issued by the Central Drugs Standard Control Organization and State Directorate of Drugs Control.

Types of Drugs License Issued by the Drugs Authority
Manufacturing License
A manufacturing license is issued to the business entities engaged in the manufacturing of drugs or drug formulations.

Drugs Sale License
This type of license is issued to the business entities or companies involved in sale of drugs. This is further categorised into two categories:
Retail License
Any individua or business entity engaged in the retail sale of drugs need to get a retail license. The term retail means the small-scale business or a pharmacy/chemist shop selling cosmetics or drugs directly to general public.
Wholesale License
A drugs wholesaler must obtain a wholesale license to carry out their wholesale business.  The term wholesale implies selling drugs to an individual or retailer to sell the drugs to another person.
About Drug Control Department and Its Services
Till 1986, the Drugs Control Department was working under the Directorate of Health
Services. Now, it functions as an independent body and the Drugs Controller acts as the head of the department.
ServicesThe Drugs Control Department provides the following provisions approved by the Government of India:
1.   Drugs and Cosmetics Act, 1940 and Rules made there under.
2.   Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.
3.   Drugs (Prices Control) Order, 2013.

Conditions for the grant of drug license
The government has imposed certain conditions required to obtain a drug license. Following are the requirements that must be fulfilled to issue a drug license. 
1.  Any individual who is a pharmacist and involved in a retail business must be trained to access a drug license. If someone has a wholesale business that person must be a graduate with 1 year of work experience or an undergraduate with 4 years of work experience.
2.   Apart from the qualification, the space requirement is another important condition to get a drug license. Any retail or wholesale business must have a pharmacy unit of 15 square meters. The area of any medical shop should be 10 square meters.
3.  A good storage facility is needed to store drugs in low temperatures along with refrigerators and air conditioners are a must for any drugs storage house.

How to Apply for Drug License?
1.  Visit the website of the concerned Drug Controller of the state. 
2.  Fill up the application form and upload the required scanned documents (100 dpi black and white) in the right format.
3.  Pay the required fees online.
4.  During the inspection, present the documents to the inspector. 
5.  Make sure the documents are filled up correctly and e-send the application. If any error is found, the application will be rejected.
6. The applicant must present the documents when asked by the licensing authority. 
7.  After the application is accepted or rejected, the applicants will receive an SMS. 
8.  Applicants should take a printout of the approved application. Henceforth, the license will be issued with e-signatures and an official seal once it is approved by the authority.

Documents Required to get Drugs Manufacturing License
1.  Application form and declaration form.
2.  Blueprint of the site plan.
3.   In case of partnership in the drug manufacturing business, proof of constitution is required.
4.  Documents to support the possession of the industrial area. If the site is rented, then a Rent Receipt & Rent Agreement attested by Notary is required.
5.   Affidavit of non-conviction.
6.   A copy of Regd. GPA / Sale Deed / Property Tax Receipt. 
7.   List of the equipment and machinery for manufacturing and testing purposes.
8.   List of technical staff for manufacturing and testing. Their photocopies (self-certified), educational qualification, experience certificate, biodata on proforma along with appointment letters and photographs.
9.  Affidavit from technical staff or employer who is working full time.
10. The product information of all the drugs, list of permitted formulations and affidavit of the owner.
11. Consent of the authorised testing laboratory for Sophisticated Testing.

To sum up, it can be said that issuance of a drugs license is vital to run a drugs and cosmetics business. Violation of the law will result in the imprisonment of the person. According to Section 18 (C) of the Drugs and Cosmetics Act, 1940, the person will be punished for not less than 1 year. This imprisonment period may extend to 3 years, and a fine not less than INR 5000. 
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