DRUG LICENCE : Throughout history, medical
advancement has played a vital role in supporting the survival of human beings and
curing life-threatening diseases. Medicine is the only weapon with mankind to fight
diseases. But medicine is not an ordinary consumable product like chocolate because
a particular drug can be used to cure a specific disease. Drugs should be taken with
the consultation of a well-educated doctor so that he can advise about how to use
when to use, what particular drug to be used to cure the disease; otherwise, it can
lead to harmful side effects. The government of Indian has formed an Act which is
known as "The Drugs and Cosmetics Act, 1940". This act provides all the
guidelines about the manufacturing, import, distribution, and sale of drugs and
cosmetics. This act also covers all the regulations of Ayurveda, Siddha and unani
Under "The Drugs and Cosmetic Act", Central
Drugs Standard Control Organization (CDSCO) provides the approval for drugs,
clinical trials, lay down of the standards of drugs, quality control of drugs etc.,
with the coordination of the authority.
In December 2020, The Ministry of Health and Family Welfare published the Cosmetic
rules 2020 that the licence is a must for the import of cosmetics into India.
"Drugs" - In pharmacology, a drug is a chemical
substance, typically of known structure, which, when administered to a living
organism, produces a biological effect.
Issuing Authority for Drug Licence
State Drugs Standards Control Organization (SDSCO)
- State Authority with CDSCO is responsible for the grant of licence who
deals in the business of Drugs & Cosmetics on the state level. The business operates
in different states, drugs sold or stocked for sale in more than one state, a
licence is mandatory for each location.
Types of Drug Licence
Drugs licence is the permission granted by the Drug
controller to deal in drugs. Kinds of the licence depend upon the type of business
1. Sales Drug Licence
Types of sales Licence are as follows
- Retail Sale Drug Licence(Chemist Shop) -
Retail sale refers to the sale of the drugs to the end consumer. Retailers can sell
drugs to a hospital, dispensary, medical, education, or research institutes, etc.
Under the Drugs and Cosmetic Act, a drugs licence is mandatory for the retailers of
drugs or Chemist shops. And a retail licence is issued by the Drug controller
Authority of the State.
In case any person sells drugs without the Licence, he shall be punishable with
imprisonment for the term of not less than 1 year and may extend up to 3 years with
a fine up to Rs. 5000.
Note - If a retailer is indulged in the drugs business in more than 1 state,
then a different licence is required for the different state.
Basic requirements for obtaining Retail Drug Licence
- Applicant premises should have an area of not less than 10sqr.mtrs.
- A registered pharmacist shall always be present in the store throughout
- Premises should have a refrigerator and air conditioner.
Document requirement for obtaining Retail Drug Licence
- Rent agreement
- Affidavit of the proprietor on stamp paper
- Self-attested ID proof and educational certificate
- Affidavit and ID Proof of registered Pharmacist
- Plan layout of premises in a blueprint
- Refrigerator Bill
- 5 Photographs of proprietor and pharmacist
- Whole Sale Drug Licence -
A wholesale licence is issued to the company/distributor/independent agent who can
be an authorized Indian agent for the local or foreign manufacturer. Or we can say
that the wholesale licence is issued to the manufacturer and authorized Indian
Whole Sale Drug Licence is issued by the CDSCO for those who deal in wholesale
distribution of Drugs.
Basic Requirements for obtaining wholesale Drug Licence
- Applicant premises should have an area of not less than 15sqr.mtrs.
- Applicant premises must have Air conditioner and refrigerator to store the
vaccines, insulin injections, sera, etc.
- Licence issues to the person who has degree or diploma in Pharmacy from a
- A pharmacist shall be a Graduate with 1 year of experience in drug dealing.
- The licence shall be displayed on the premises.
Documents required for obtaining wholesale Drug Licence
- Incorporation certificate, MOA or AOA, Partnership deed as applicable
- Proof of the ownership
- Cover letter with name and designation of the applicant
- Challan of fees deposited for the license
- Declaration form in a given format
- Key plan and site plan of the premises (Blueprint)
- The documents of possession of the premises
- Affidavit regarding non-conviction under the Drugs and Cosmetic Act 1940,
signed by proprietors, partners, directors as the case may be
- Appointment letter on being appointed as a full-time registered pharmacist
- Restricted Licence for Drugs -
Under Form 20A and 21A, this licence is issued to those applicants who want to sell
drugs without the supervision of a competent individual.
2. Manufacturing Licence for Drug
Manufacturing licence is granted to the manufacturer
of Allopathic and Ayurvedic drugs and cosmetic products; a licence is granted by the
concerned State government of the manufacturer.
Types of manufacturing licence
- Test Licence for Manufacturing - Form -29, this licence is issued by the
Zonal Office and State licencing authority for the purpose of examination.
Testing and analysis of drugs in small quantities and also given for the import
of small quantities of drugs for examination, testing and analysis.
- Post successful clinical trial manufacturing licence - Form -46, Licence
permitted to manufacturing for sale of medical devices which are new in the
market, and a clinical trial is not done.
- Notified medical devices manufacture licence - Form -28 Form - 27This
licence is issued to the manufacturer of disposable hypodermic syringes and
needles, cardiac stents, catheters, IVD Devices for HIV, HBsAg, HCV, etc.
Basic Requirements for obtaining manufacturing Licence
- Factory premises should be according to the standard schedule M.
- The factory should be well equipped, have adequate space for machinery.
- Should have well qualified to carry out the analysis at the testing center.
- Should have adequate laboratory equipment for testing.
- Adequate drug storage arrangements should be made.
- Conform to Good Manufacturing Practices standards.
Documents required for obtaining manufacturing Licence
- Constitution of the Firm (MOA/AOA)
- ID Proof of the partner/director/proprietor
- Address proof of the owners
- Copy of Property paper/Rent agreement
- The site and key plans of the premises (Blue Print)
- Invoice and details of Refrigerator and Air Condition Purchased for business
- Mention purpose of the application on Cover Letter
- Self Attested of registered plant layout
- List of technical staff with ID Proof, qualification, experience letter,
appointment letter, and 3 photographs
- Machinery list
- Laboratory equipment
- NOC of pollution control and fire fighting
- Nominate authorized Indian Representative
3. Loan Drug Licence
According to the drug and cosmetic act," A loan
license means a license which a licensing authority may issue to an applicant who
doesn't have its own arrangement of manufacturing but who intends to avail himself
of the manufacturing facilities of a licensee.
4. Import Licence
Under Schedule X, Drugs & Cosmetics can be imported to India only after obtaining a
Licence. Not only drugs shall be registered, but the manufacturing unit should also
be registered for import purposes.
5. Multi-licence for Drug
This licence is for those applicants who operate their business in more than one
state. Without a multi-drug licence, you cannot sell drugs in more than one state.
- Documentation -
Its process starts with the documents, as documentation depends upon the region
and type of business like a retailer, wholesaler, manufacturer, and importer.
Without documents, no application can be filed, or we can say without complete
documents, no licence will be granted.
- Submit application -
After compiling the documents, submit the complete application with appropriate
information with Drug Control Authority.
- Inspection of the Premises -
Drugs inspector appointed by the authority conducts the audit to inspect the
premises in order to check whether details provided by the applicant are correct
- Scrutiny of application -
Drugs inspector will verify the details of the application. If he finds
everything satisfactory, then Licence will be granted. In case he raises the
query applicant must reply within 3 days in an appropriate manner.
Unsatisfactory reply can lead to cancellation of licence.
- Grant of Licence -
After getting satisfied with the documents, the Drug control department issues
the Drug Licence.
30 working Days
Issued Licence is valid for 5 years
Licence can be renewed by providing requisite
documents for renewal, and authority will renew the licence for a particular time
Why to choose ALEPH INDIA for Drug Licencing?
A drug licence is required to start a pharmacy
company. Whether you are a retailer, distributor, or manufacturer of
pharmaceuticals and cosmetics in India or abroad, you may contact ALEPH INDIA
directly for any sort of drug licence. ALEPH INDIA ensures that you will receive
your licence at an appropriate time, and the licence will increase the
reputation of your drugs in the eyes of the public. We are offering a complete
solution for drugs manufacturer in obtaining the Licence and testing facility in