Drug License

The Indian pharmaceuticals market is the 3rd largest in terms of volume and 13th largest in terms of value, and it accounts for around 20 percent in the volume terms and 1.5 percent in value terms of the Global Pharmaceutical Industry. 

The Indian pharma industry is projected to grow over 16 percent per annum during the period 2015 till 2020 as compared to global pharma industry's 5 percent.  There is a huge potential in Indian pharmaceuticals industry which opens door to entrepreneurs and start-ups involved in pharma business.  As per Drugs & Cosmetics Act, 1940 Drug License is mandatory throughout India for carrying out the business related to pharmaceutical industries that deal with drugs, medications and cosmetics. To do business in pharma industry including Ayurvedic & Unani drugs, one must get a Drug license to operate legally. 

There are more than 10 different types of drug licenses. However, a business unit may require a particular license based on their business requirement. Drug license is issued subject to certain conditions attached to premises and the competent person who shall be dealing with drugs.

• A registered pharmacist should directly and personally supervise any drug made by the licensee.
• The licensee should have a minimum of four years of practical experience in the distribution of drugs.
• The retail supply of any drug prescribed by the registered medical practitioner should be under the inspection of a registered pharmacist.
• The retail supply of the drug should be recorded in a register at the time of supply.
• The drugs mentioned in Schedule H or Schedule X are valid for a period of two years and should be supplied to registered Medical Practitioners, hospitals, dispensaries and nursing homes only on the signed order in writing.
• The licensee should maintain the purchase record of the drugs intended for sale or sold by retail.
• The licensee should not sell or stock any drug after the expiry date.
• The licensee should not store or stock any drugs on his premises that are intended for distribution as a free sample to the medical profession.
• The medicine in a retail shop for the treatment of animals should be labelled as “Not for human use - for treatment of animals only.” medical shop licence cost

Note: The expired drugs stored to claim a rebate from the income tax will not be considered an offence under the act unless not intended for sale.

• Manufacturing License: The manufacturing license is issued to a firm that is into the manufacturing of allopathic/homeopathic drugs. 
• Sale License: The sale license has two subcategories depending upon the type of activity the firm is indulged in.

1. Drug Wholesale License: If the applicant’s firm is a wholesaler of drugs then, he must get himself registered under the wholesale category in order to wholesale drugs.
2. Drug Sale License: If the applicant is willing to sell the drugs through a retail shop, dispensary, hospital, etc. Then he must get himself registered under the Drug Sale license application only. 

• Loan License: A Loan license is granted to the applicant who is using the resources of the other registered manufacturer (resources like Machinery, staff, equipment, etc.) to get their drugs manufactured as per the Drugs and Cosmetic Act.
• Import License: In case the applicant is willing to import drugs in India from any foreign nation, he/she needs to apply for an import license with CDSCO to obtain the necessary permits to sell them in India.

Essential Requirement for Obtaining a Drug License in India:

Requirement of space: One of the important requirements for obtaining a drug license is to have a bare minimum space of 15 square meters for a wholesale license and 10 square meters for a drug sale license. The height of the ceiling must be as per the National Building Code of India, 2005. Also, the applicant needs to have a layout plan of the premise depicting all the dimensions of the space.

A registered pharmacist: The applicant firm whether wholesale or retail must have at least one registered pharmacist with in-depth knowledge in order to operate as per the Drug and cosmetic act 1940. Also, the license issued to the pharmacist by the pharmacy council of India must be valid with a valid registration date. In case the license of the pharmacist is expired, the pharmacist must renew his/her license before applying for the drug license.

Location: A drug License is not granted to a premise located on a DDA-allotted residential plot/land or flat unless it fulfills the requirements of MPD-2021.

Storage Facility: The applicant must have a proper storage facility for the drug license. In case the firm deals in drugs that are required to be kept at a low temperature then it is mandatory to have a refrigerator and air conditioner.

The food and Drug association of India has made it mandatory to provide certain documents while applying for a drug license. The list of mandatory documents are mentioned below,

• Affidavit attested by Public Notary:

1. Of Proprietor, if the applicant firm is proprietorship firm.
2. Of all the partners, in case the firm is a partnership firm.
3. Of the person duly authorized by the Board of Directors of the Private Limited of Limited Company

• Copy of partnership deed if partnership firm
• Address proof of the authorized proprietor/applicant (copy of voter I.D., driving license)
• Affidavit of the liable person for day-to-day working and for any violation of laws pertaining to Drugs.
• Documents related to Pharmacist:

1. Affidavit duly attested by Public Notary.
2. Copies of educational qualification certificates (Attested)
3. Attested copy of registration certificate and its renewal issued by U.P. Pharmacy Council.
4. Two photographs per applied license.
5. Address proof.
6. Appointment letter and joining letter

• Documents related to qualified person (for Wholesale license):

1. Attested copies of educational qualification certificates
2. Experience certificate on the affidavit
3. Two photographs per applied license
4. Appointment letter and Joining letter if applicable
5. Three copies of the plan of the proposed premises.

• Documentary proof of rental or ownership basis of the proposed premises

1. Photocopy of the rental agreement in case of rented premises.
2. Attested copy of ownership proof of rented premises from the landlord.

• Two photographs of Proprietor/Partners/Authorized person.
• Attested copy of purchase invoice of a refrigerator

• Login credentials: The very first step for the drug license registration is to get the applicant registered on the drug licensing portal. Once the applicant is registered on the portal, login credentials are received over the registered mobile number or email ID.
• Registration of pharmacist and competent person: Once the user gets the login credentials across its portal. He/ she needs to update the details of registered pharmacists and competent people.
• Application filling: Post registering pharmacist and competent person, the applicant needs to submit all the requisite details and upload necessary documents. Once done, the application is submitted to the department and the requisite fees are paid. 
• Inspection: Post submission of application online, the Drug Inspector visits the premise for authentication of site and verification of original documents. Post-inspection the Drug Inspector submits the inspection report to DLA, on the basis of which the final license is granted.

While applying offline, the fees should be paid in the Government Treasury or Government Branch of State Bank of India of the district where the license is required. The original treasury challan must be submitted with the application.

Corpseed being a single-stop solution service facilitate and ensures a hassle-free registration for Drug sale licenses. We at Corpseed facilitate end-to-end solutions for all Indian Regulatory compliance.

• Assistance in preparing and managing documents
• Application filling    
• Liasioning with the department officials on behalf of the applicant
• Timely approval in predefined ETA
• Quality service with minimum charges