Drug 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: Step 1 – Official Website The applicant may initiate the proceedings by visiting the official website meant for this purpose. Step 2 – Generate Login Credentials The option “New login ID and PWD” (which is found on the right-hand side of the webpage) must be opted for. Choose the option ’MH’ from the drop-down menu. Step 3: Fresh License or Renewal In the following page, the user will be presented with two options, among which the first one is meant for existing license holders and the latter for new applicants. Choosing any of the options will direct the applicant to a page for specification of information, which must be duly filled and saved. The User ID and Password will be delivered to the registered mobile number of the user within 24 hours. Step 4: Login The user may log in to the portal by entering his/her username and password. Step 5: Prepare/edit Online Application Choose the option ‘prepare/edit online application’, which can be found in the left-hand corner of the page. Step 6: New Inward Option Click on the ‘Inward button’ found on the page and opt for the desired ‘Inward type’. Step 7: What are you applying for? Choose the option for which the application is made for. Step 8: Entry of Information Specify the required data and save it. Step 9: Print Out The user is required to take a print out of the application and duly sign the same. Step 10: Uploading of Documents The required documents must be uploaded, after which the user will be directed to the payment gateway. Step 11: Remittance of Fees Upon the completion of the inward application procedure, the applicant would be necessitated to remit payments. This can be done through the ‘makepayment’ tab which appears after the process of inward application is done with. Clicking on this will take the user to the ‘make a new payment’ tab,’ thereby redirecting the user to the ‘Gras’ site of the Government of Maharashtra. Step 12: Time to Make Choices The applicant will now be asked to make his/her choices, the likes of which include:

Department (the option Food and Drugs Administration is apt for this purpose).
Payment types (choose the category for which the payment is to be made); e.g. – drug sale license.
Scheme name
District of enrollment.
Name of the office.
The period for which payment is being remitted.
Form ID.
Options of payment.

Step 13: Deposit of Money The payment can be remitted based on the module chosen by the applicant, courtesy the GRAS website. Step 14: The Final Act After the payment is deposited through the GRAS System, a payment receipt may be printed and uploaded in the system, post which the application can be forwarded to the department. This concludes the application process. The concerned authorities will review the application upon receiving it. Queries are raised by the inspector and/or Licensing authority or Assistant Commissioner for incomplete and inadequate submissions. If unsatisfied with the response of the applicant, the certificate will be reverted back to him/her so as to resubmit the same by making the necessary changes.

Classification as Spurious Drug

A drug will be classified as spurious if:

It is imported under a name of a different drug.
It intimates/substitutes another drug in a manner that the name of such drug is identical to that of another except if it’s plainly and conspicuously marked to reveal its true character and its lack of identity with the latter.
The label of the container of the drug is identical to the name of an individual or company claiming to be the manufacturer of the drug, the likes of which is fictions or non-existent.
It purports to be the product of a manufacturer who holds no ownership rights for the same.

Also read: Rajasthan Drug License Drug License in Andhra Pradesh Drug License in West Bengal