License in Maharashtra

Drugs are one of the most prized yet potent inventions of mankind; the proper utilization of which hinges on its regulation. In India, drug control is exercised throughout the entire life cycle of the drug; which involves its manufacture, sale, distribution, and consumption. This article looks at the requirements and procedure to obtain a drug license in Maharashtra.

Governing Act

India’s drug industry is primarily regulated by the Drugs and Cosmetics Act of 1940 among other relevant regulations such as the Dangerous Drugs Act of 1930 and other relevant regulations. The year 1964 marked the inclusion of Ayurvedic and Unani drugs into the former Act, which was until then kept out of the purview of this provision.

Armband of Execution

The administration of drugs in Maharashtra is vested with the Food and Drug Administration of the State. The administrative body, which is headquartered in Mumbai, strives to enforce the relevant Acts in a fair manner by upholding the safety standers and protecting consumers through it.

Infrastructural Specifications

A retail or wholesale operational unit for drugs can be established in a carpet area of 10 square meters and must include a separate and exclusive entrance. On the other hand, an outlet operated for both retail and wholesale purposes must be established a carpet area of 15 square meters. In case of the latter, the area must be legally possessed by the applicant, and again, must include separate and exclusive entrances.

Interior Specifications

The medical facility must include a refrigerator for the storage of certain vaccinations and medicines. Apart from this; cupboards, racks and other pertinent utilities are required for the storage of drugs.

>Appointment of Personnel

The operations of a retail medical store can be entrusted to a registered pharmacist. A wholesale store owner may either avail the services of a competent person holding a graduate degree with more than a year of experience in the procurement and sale of drugs or a Registered Pharmacist.

Fee Requirements

Retail Chemist Shop Licenses for sale of Allopathic and Homeopathic medicines can be availed by remitting a fee of Rs. 3250. Wholesale shop licenses (whether a fresh one or the renewal of an existing one) can be availed by remitting a Fee of Rs 3000. Wholesale shops specifically dealing with Homeopathic medicines requires a remittance fee of Rs. 250 so as to be licensed. Retail sale of Schedule X drugs can be pursued by paying a fee of Rs. 600. Wholesale outlets are required to remit a sum Rs. 1200 to avail the same provision.

Documents Required

Let us understand the documentary requirements for various licenses issued under the umbrella of trade license:

Fresh Application of Retail/Wholesale License

Application form in Form 19 (for Retail license), Form 21 (for Wholesale License), Form 19B (For Retail Homeopathic license), Form 20C (for Wholesale Homeopathic License), Form 19C (for Retail and Wholesale license of Schedule X Drugs), and Form 19A (for Retail Restricted license). For the awareness of the applicants, these forms need not be signed by all partners given its statutory nature. Photo ID (for proprietorship firms). Scanned PDF of the partnership deed and the receipt of the Registration fee paid to the Registrar of Companies (for partnership firms). Documents of Trust Registration issued by the charity commissioner. HUF Deed (for HUF’s). Deed and Registration Certificate of the Society (for Societies). Letter from the Head of Department of the Government. List of the Proprietor/Partner/Director/Trustee, etc. Proof of Identity of the concerned applicants. Rental/Lease agreement of the proposed premise (conditions apply). Proof of Ownership of the premise. No Objection Certificate (for Societies, residential premises leased by CIDCO, MHADA or similar Government/Semi Government Agencies). Electricity bill of the premises. Layout of the building. Proof of installation of Cold Storage facilities. Appointment letter and acceptance letter of the pharmacist, along with his/her residential proof. Registration Certificate (for retail license). Self-declaration of the pharmacist (for retail license). Qualification Certificate (for Whole Sale License). Experience Certificate of the Pharmacist (for Whole Sale License).

In the Event of Change in Constitution

Duly-filled in application form. A letter declaring the change in constitution. Documents of the firm’s constitution. Details of the Proprietor/Partner/Director/Trustee, etc. Revised rental legal agreement (if applicable). Ownership documents of additional premises.

Change in Premises

Duly-filled in application form. Proof of ownership of premises. Rental/lease agreement. NOC (if applicable). Electricity bill of the premises. The layout of the plan.

For Additional License

Duly-filled application form. Documents of the Registered Pharmacist (if a wholesaler is applying for retail license).

For Retention of License

Submission of online application. Copy of the receipt license of the retention fee paid.

For Change in Pharmacist

Certificate of Registration. Self-declaration form (duly signed by the pharmacist and employer).

For Change in Competent Person

Appointment letter and acceptance letter of the competent person. Proof of residence of the competent person. Educational qualification certificate of the competent person. Experience certificate of the competent person.

For Addition or Reduction in Premises

Revised Rent/Lease agreement. Proof of ownership of the premises. Revised plan of the layout.

For Change in Specific Condition

Proof of installation of cold storage facilities. 24 hours open application – only with three pharmacists and safety measures.

Surrender of License

Letter for surrender of license (duly signed by proprietor/partner/legal heir/director/authorized signatory).

Duplicate License

Application in plain paper.

Change in Director

Form 32 of the incoming director.

No Conviction Certificate

Self-declaration in the specified format. Copy of tender.

Application Procedure

As we have now covered the fundamentals, let us analyze the procedure to apply for this vital document: