Drug Licence In India
Generally, across the world, it is a common practice that to set up business in any sensitive sector, or to manufacture items that will affect lives of humans and animals or affect the health of the environment, permits, licences etc are required form the overseeing authority- called the Government. In India too, such sectors are regulated and registration/ application has to be done with governmental authorities to set up such business / manufacturing units etc. To trade or do retail business, a Trade License will be required. This is not as much a permission as a registration that taxes the trader for using scarce resources and using the communal areas for commercial purposes. For manufacturing, earlier installed capacity would require government permission, but now information has to be given and registration obtained for using scarce resources like water, electricity. Disposal and treatment of waste products generated will require submission of information, adherence to pollution norms and reporting of how contaminants etc are being treated before being released into the environment.
Thus from a regulated industrial world, we have moved towards seeking registrations through applications in most of the sectors and supplying information and adhering to standards to maintain equilibrium.
Need Of Drug Licence in India
To start a pharmaceutical manufacturing unit in India, a drug licence is needed. The entity has to apply for a licence that will be issued by the Central government through Central Drugs Standard Control Organisation (CDSCO) or through the State Drug Control Department. The entity- sole proprietorship, partnership, LLP, Company may be involved in the manufacturing, trading, distribution, or importing of medicines in any form whatsoever.
By making the registration and issuance of Drug Licence mandatory, the government wants to ensure the following:
- Maintain the the safety, quality and legitimacy of pharmaceutical products in the country
- To regulate and control the drug sector
- To safeguard public health
- To prevent circulation of sub-standard or fake drugs
- to check that the drugs being manufactured, sold, or distributed have complied with the standards as set out by the Drugs and Cosmetics Act, 1940 and the relevant Rules of 1945.
Acts and Rules that govern the Drug Licence In India
The Acts and Rules that govern the Drug Licensing in India are:
Acts:
- The Drugs And Cosmetics Act, 1940
- Narcotic Drugs and Psychotropic Substances Act,1985
Rules:
- The Drugs And Cosmetics Rules, 1945
- The New Drugs And Clinical Trials Rules, 2019
Intention behind Drug Licence in India
It is the duty of the regulatory authority to ensure that medicines and drugs manufactured in the country are easily available in the markets. That the price of such medicines/ drugs are affordable for each and every section of the society.
Further, the medicines produced in the country are free from any defects and the quality of medicines produced are of good quality and are fit for human use. Thus, while granting drug licence for sale, manufacturing and/ or distribution the government has to take proper care along with considering the consequences or adverse effects of such substances when they will be ingested or administered to a human body. To reduce the risk and protect the general public from any adverse effects of drugs / medicines that will be allowed to be sold in the open market, the government has laid down specific and stringent rules and regulations that have to be complied with when issuing the licence of sale or manufacturing of drugs or medicine in India.
The Drugs and Cosmetics Act, 1940 has defined ‘drug’ as:
- inclusion of all medicines and medical devices for use in the treatment of illness/ diseases of humans or animals, whether taken internally or applied externally and all other substances which are to be used in the diagnosis, deterring or removal/reduction of any ailment, disease or sickness in humans and/ or animals.
- It also includes preparation or concoction applied to the human body for different purposes like repelling of insects or curing of minor infections.
- It also includes substances or chemicals used to destroy or kill insects.
- It also includes substances used to cover the drugs that also form a part of the drug such as empty gelatin capsules.
- Ayurvedic and Unani drugs too have been included in its definition.
Various types of Drug Licences available in India
There are various types of drug licences issued by Central Drugs Standard Control Organisation or CDSCO depending on the activities and scope of the pharmaceutical business.
The different types of drug licences that can be applied for are as follows:
1. Manufacturing Licence:
a. Manufacturing Licence: for entities engaged in large/ medium/ small - scale drug manufacturing.
b. Loan Licence: For entities that outsource the manufacturing process to a third-party.
2. Sale Licence:
a. Retail Drug License: for retail pharmacies or chemists for sale of drugs and medicines directly to consumers.
b. Wholesale Drug Licence: for wholesalers or distributors for the sale and distribution of drugs to retailers, hospitals, and other facilities.
3. Restricted Licence:
Restricted Licence for the sale of specific drugs or categories of drugs, such as narcotics, psychotropic substances, etc.
4. Import Licence:
Issued to entities involved in importing drugs and pharmaceutical products from other countries.
5. Loan License for Repacking:
Issued to entities engaged in repacking or re-labelling of drugs.
6. Blood Bank License:
For establishments or entities that are engaged in collection, processing, and storing of human blood and its components.
7. Homoeopathic Drug Licence:
For entities who manufacture or are retailers or wholesalers of homoeopathic medicines.
8. Ayurvedic Drug Licence:
For entities who are manufacturers, retailers, or wholesalers of Ayurvedic medicines.
9. Cosmetic Licence:
For entities engaged in the manufacturing, sale, or import of cosmetic products.
10. Medical Device Licence:
For entities engaged in manufacturing, importing, or selling of medical devices.
Steps for making an application for Drug Licence in India:
1. Understand the type of Licence that you want to apply for:
Read the above point related to the different types of licences that can be applied for like; manufacturing, retail, wholesale etc. Then choose the one that you want to apply for. You may select multiple licences and apply for them separately.
2. Understand the eligibility criterias of making the application:
The forms state what basic requirements have to be fulfilled in terms of eligibility criteria- and documentation requirements.
3. Compile Required Documents:
Gather all the relevant supporting documents, for example:
- Proof of identity of the applicant
- Proof of address of the applicant
- Proof of the premises under which the application is being made. (e.g., ownership papers, lease document etc.).
- Factory layout plan (for manufacturing licences).
- Details of technical staff (for manufacturing and wholesale licences).
- List of drugs to be manufactured
- Qualification certificates of the registered pharmacist (for retail licences).
- Import-export code (for import licences).
4. Complete the Application:
Fill all the required data in the form and make attachments to the form
5. Submit the Application:
Submit the completed application form along with the supporting documents with authority or online portal making sure that all required details are properly filled up and documents have been attached, duly certified, to the application.
6. Pay the Application Fee:
On submission of the form, the payment has to be done either in online or offline mode.
7. Application Processing:
The regulatory authority will check the application and verify the submitted documents. Thereafter the application may undergo scrutiny, inspection or assessments.
8. Compliance and Inspections:
Physical inspection of the premises may be conducted. The applicant should have the premises ready for such inspection along with any other preparations that have to be made to get the inspection carried on smoothly
9. Licence Issuance:
If all the steps are carefully and properly carried out, the authority will issue the licence. It will specify the validity period, terms and conditions, and any other specific obligations to be fulfilled on a regular or periodical basis by the entity in whose name the licence has been issued.
Forms required for application of Drug Licence in India
1. Form 8 (Rule 24):
Application Form for Import License
This is for applying for an import licence for drugs and pharmaceutical products. Data required- details such as the applicant's personal information, IEC (Import Export Code), manufacturer details, product information, and quality control measures.
2. Form 24 (Rule 69):
Application Form for Grant / Renewal of Wholesale Drug License
This form for applying for obtaining or renewing a wholesale drug licence. It includes details such as the applicant's personal information, premises details, storage facilities, and qualifications of the competent technical staff.
3. Form 24-A (Rule 69):
Application Form for Grant / Renewal of Retail Drug License
This form is used for obtaining or renewing a retail drug licence. It includes information about the applicant, premises details, qualifications of the registered pharmacist, and details of the drugs to be sold.
4. Form 24-B (Rule 69A):
Application Form for Grant / Renewal of Restricted License
This form is used for applying for a restricted licence for the sale of specific drugs or categories of drugs, such as narcotics or psychotropic substances. It requires details about the applicant, premises, storage facilities, and a list of drugs for which the licence is sought.
5. Form 25 (Rule 70):
Application Form for Grant / Renewal of Manufacturing License (Allopathic Medicines)
This is for applying to obtain or renew a manufacturing licence for allopathic medicines. Information required to be given- details about the applicant, of the manufacturing premises, infrastructure that has been created, list of the competent technical staff, quality control measures etc.
6. Form 25-A (Rule 70A):
Application for Grant / Renewal of Manufacturing License (Ayurvedic/Siddha/Unani Medicines)
This is for applying to obtain or renew a manufacturing licence for Ayurvedic, Siddha, or Unani medicines. IInformation required to be given- details about the applicant, of the manufacturing premises, infrastructure that has been created, list of the competent technical staff, quality control measures etc. specific to these systems of medicine.
7. Form 25-B (Rule 70):
Application Form for Grant / Renewal of Manufacturing License (Homoeopathic Medicines)
This form is used for obtaining or renewing a manufacturing licence for homoeopathic medicines. It includes information about the applicant, manufacturing premises, infrastructure, qualified personnel, and quality control measures specific to homoeopathic medicines.
These forms are available on the official website of the Central Drugs Standard Control Organisation (CDSCO) and the respective State Drug Control Department websites.
Conclusion:
In conclusion, getting a drug licence and displaying the same in the premises, sends a message across to all other entities that will deal with the applicant that the basic checking has been done by the government and the applicant has suitable setup to enter into dealings and prepare /market/ trade in drugs / medicines that is fit for human consumption.
Compliance with the law of the land, inspections by the regulatory authorities, and periodic assessments ensure that the business that deals with the health and life of humans has followed a process of check and balances.. By following the proper procedures and submitting all required documents, pharmaceutical businesses can obtain the necessary drug licence to operate legally and contribute to the safe and effective distribution of medicines in the country.
