Drugs are an essential part of the medical and biotechnological field as they are a cure for numerous diseases. The medicinal use of drugs is growing day by day hence, its accessibility has also become very easy as it is available in every corner of the country. Everything has its pros and cons and the easy access to drugs has led to its severe misuse. To curb the growing misuse the Government of India has made the rules for the sale of drugs very stringent and every dealer or pharmacist has to obtain a drug sale licence by filing a Drug Licence Application form. Even a wholesaler who imports or exports drugs has to get a licence by filing a Drug Licence Application form. Drugs and Cosmetics Act, 1940 governs the use of drugs in India from its manufacturing, import, processing and sale in the country. There are penalties and strict detention if the sale is unlawful and without the proper procedures or a drug sale licence laid down by the authorities.
Authorities for Drug Sale Licence in India
The authorities which look into the Drug Licence Application for drug sale licence are –
- CDSCO (Central Drugs Standard Control Organization) – It is responsible for issuing licences for New Drug Approvals, their testing and their market circulation as and when required. It coordinates with the SDSCO for the distribution of drugs and their fair use in the country.
- SDSCO (State Drugs Standard Control Organization) – It is responsible for issuing licenses for the purpose of sales, distribution, and manufacture of drugs in their respective states.
- Department Of Ayush – This department issues licenses for the purpose of Ayurveda, Siddha, Homeopathy, Unani and herbal products for medicinal and cosmetic use.
Different Types of Drug Licences in India
There are different types of drug licenses in India that are granted through the Drug Licence Application. There are different fields like manufacturing of drugs, processing, importing/exporting, sale, etc, which require a Drug licence through SDSCO or CDSCO. The person or an organization applying for it needs to submit a Drug License Application to the authorities and follow the procedure to obtain the license. Certain types of licences which one might require are-
1. Sale of Drug Licence
This licence is mostly required by the chemists, pharmacists or wholesalerswho deal in the retail sale of the medicines to the general public. The sale of medicine requires a Drug sale licence to operate because if it is not obtained by the retail shops the misuse of these drugs would increase considerably and there can be many crimes with its use. These drugs are very harmful if not taken in the prescribed manner or taken more than required. Hence, the retail shops and the sellers must file a Drug Licence Application or a Wholesale drug application with the state authorities to get the licence in order to continue the sale of medicines for medicinal purposes.
- Drug Licence for retail sale – Retailers sell drugs through medicines directly to the public which includes healthcare institutions, schools, research institutes, the general public, etc. There are certain requirements for them to meet in order to get the Drug sale Licence when they are applying for the drug licence application. In case the requirements are not met as set by the authorities the person would be liable for a punishment of 1 year which may extendto 3 years and a fine up to Rs 5,000.
- Drug Licence for Whole Sellers–The wholesalers sell the medicines in bulk mostly to retailers like pharmacists and chemists and for that, they have to apply for the drug licence application. They are also involved in the import and export of medicines for which they need a licence from the regulatory authorities and to obtain the licence they have to fill out the Wholesale drug application and get it approved. If you have a state licence of One state then in that case you cannot sell those drugs in any other state without the licence.
2. Manufacturing Licence
Manufacturers dealing in Allopathic, Homeopathic, Ayurvedic and Cosmetic drugs need to get a manufacturing licence by filing the Drug Licence Application from the authorities to make the drugs as per the requirement. These manufacturers need to have set the manufacturing units as described by the government. The personnel appointed for various purposes should be qualified enough and trained to fulfil the purpose. Any disregard for the code would lead to the cancellation of the Drug sale Licence. The process of manufacturing can only proceed after getting the new drug approval from the government.
3. Loan Drug Licence
A drug Licence Application is filed for obtaining a Loan drug licence as well since the licensee would be dealing in drugs. This licence may be issued by the licencing authority to any applicant who does not have any manufacturing unit but can arrange himself a unit of another licensee. The authorities give the drug sale licence only if they are satisfied that all the necessary documents and criteria are met while filling out the Drug Licence Application. A new drug approval is also required if some new drug is being manufactured by the Loanee.
4. Import Licence
If the medicines and drugs are being imported to India, they need to get an import licence and the manufacturing unit which is getting the drug imported also needs to get the licence through the drug licence application.
5. Multi-drug Licence
The dealers who operate in more than one state need to get a license for the same since the policies of each state differ from the other and one needs to get a license to operate in different states.
Key Requirements to Get a Drug Licence
- Qualified Individual –The pharmacist has to be qualified enough to run a pharmacy. He/ She should have a good knowledge about the medicines and should sell the medicines only after a consultation or a prescription from a doctor. When it is a wholesale business the person in charge should hold a graduate degree in the required field with at least one year of experience, if he/ she doesn’t have a graduate degree in that case a minimum of 4 years of experience in the field is required. Failing to do so, the drug sale licence might be terminated.
- Space –The other key requirement is the space of the operating unit. If it is a retail unit then the minimum required area is 10 square meters and in the case of the wholesale unit the minimum area should be 15 square meters. The units would also be measured in terms of height and it would be according to the guidelines set by the National Building Code of India, 2005.
- Storage –The facilities of storage are also a key factor since few drugs require very low temperatures to be kept under. The optimum temperature has to be maintained for specific drug types to prevent them from getting damaged. So, the unit must have a refrigerator, air conditioner and separate shelves for different kinds of drugs.
- Competent Staff –The staff should be competent enough to differentiate between the drugs. If a different drug is given to a person than what was required it may even cause death. Staff should be qualified enough to read and understand the prescription of the doctor.
Drug Licence Application for New Drug Approval
To obtain a licence for drug/ new drug approval one needs to fill Drug Licence Application and then the regulatory authority for drugs assesses the application and grants or even denies the application. There is a certain procedure which is needed to be followed, which is as follows:
- Login through the website of the respective authority
The person applying for the licence must visit the website online of the concerned authority (SDSCO/ CDSCO/ Ayush) to fill out the application. These authorities are responsible for granting licences as per their jurisdiction and scope.
- Drug Licence Application
The Licensee has to fill out the application form with all the details which are asked in the form including the personal details. For example, if a person wants a Wholesale drug Application, then he/ she has to fill out that form and has to meet all the required conditions in order to get the drug sale licence.
- Documentation
After the necessary details are filled, the applicant needs to provide all the documents in order to verify themselves. Along with the documents, there is a desired fee for each type of application, hence, it needs to be paid to obtain the licence.
- Drug inspector visit
After the documents are provided and approved the authority assigns a drug inspector who visits the applicant’s place of business/ unit to confirm the details shared by him/ her in the documentation process.
- Licence
After the documentation process is complete and the drug inspector is satisfied with the details provided in the documentation to be met with the set criteria, the licence is given to the applicant which is for a certain period of time and not for a lifetime. The applicant has to renew the licence once it has expired.
Necessary Paperwork for getting Drug Licence
The necessary paperwork for getting drug license are:
- Constitution of the institution dealing in drugs, Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, and LLP agreement for a partnership or LLP.
- Proof of identity for partner/director/proprietor.
- Documents linked to the premises- Copy of the property’s ownership paperwork or rental agreement, as well as the NOC (No Objection Certificate) from the owner of the rented premises, where applicable.
- Site plan along with the key plan for the property.
- A copy of the Board resolution authorizing the acquiring of a license.
- Proof of the availability of storage capacity, such as a refrigerator or cold storage unit.
- A copy of the challan serves as proof of the deposit fee.
- Affidavit of non-conviction for the proprietor/partner/director and the firm.
- An affidavit from a registered pharmacist or competent person.
- Provide a cover letter containing the applicant’s name and designation, as well as a declaration form in the approved format.
- Qualification certificate of the applicant
- In case of retail sale, the pharmacist must submit his/ her proof of qualification, registration certificate at the local pharmacy council and the letter of appointment
- In case of a wholesale sale, the pharmacist must submit his/ her proof of qualification, a letter of appointment along with certificate of experience.
Conclusion
A drug licence is a must to carry out the drug sale in any region. A drug Licence Application needs to be filled out before commencing the business to avoid legal issues. Correct documentation leads to a comparatively easy and fast Drug Licence Application approval. One has to follow the guidelines set to get the drug licence hassle-free.
Corpbiz can help you get a drug license by getting the Drug Licence Application approved in a very short period, and you can easily start your business in India.
Frequently Asked Questions
The purpose of granting licences to all kinds of drug sales by the government is to avoid any kind of misuse of these drugs at any level. The drugs used for medicinal purposes can be affected very severely if consumed without a prescription or overdose. There are all kinds of drugs in the market which only qualified personnel can access since they can harm any individual if consumed.
The authorities have set the guidelines to renew the drug licence after every 5 years. After 5 years the previous licence would not be deemed valid and there will be certain penalties if drugs are sold after the expiration period.
Form 24 D has to be filled in order to obtain or renew a drug sale licence for Ayurvedic purposes.
No, the sale of drugs is not possible in Delhi since you do not have a drug license from Delhi state government through SDSCO. Only after obtaining the licence from the state in which you want to run the business, you are allowed to run its operations, since every state has its own Drug Licence Application process.
There are a few basic requirements to get a wholesale drug licence:
1. The operating area must be 15 square meters or more.
2. There must be AC and refrigerator in the premises since some medicines and drugs need lower temperatures otherwise, they will get spoiled in very little time.
3. The person in charge must have a degree or a diploma in the medicinal field in order to get the licence.
4. Pharmacist must be a graduate with at least 1 year of experience in the related field.
5. The licence once obtained from the authorities must be on display to be seen easily.
Form 44 deals with any new drug manufacturing or its import or even its clinical trials in the country.
Since every state has its separate drug licence authority, Delhi too has it and it is known as Delhi’s Drug Control Department. The department is liable for granting licences related to drug manufacturing and sale on the premises. Delhi being a big state has two divisions for enforcing drug laws. These divisions are bifurcated zone-wise –
• North West Zone
• South East Zone
Read Our Article: Drug License for Wholesale Business in India
