In order to understand the concept of getting a drug license in Maharashtra, it is important to understand the term “drugs”, whichcover a wide range of medicinal implements and products, such as pharmaceuticals, cosmetics, laxatives, chemicals, stimulants, anti-depressants, etc. Though medicinal drugs differ from narcotic substances, the use and abuse of both have been a pertinent issue before the enforcement agencies and hence, there are very strict compliance requirements applicable to the stakeholders of the drug manufacturing business. The State of Maharashtra, particularly, has very stringent drug licensing requirements; therefore, obtaining a drug license in Maharashtra requires much diligence and careful submission of documents to the regulatory authorities. Drug manufacturers and distributors in India are governed by the Drug and Cosmetics Act, 1940 and Rules,1945, which lays down the process and legal requirements for the purpose of obtaining a drug license in Maharashtra.
Applicable Laws and Governing Body for Drug License in Maharashtra
The drug license in Maharashtra is governed by the Maharashtra Drugs (Control) Act of 1960, Drugs and Cosmetics Act, 1940 and Rules,1945, and is administered by the Food and Drug Administration (FDA). The manufacturers and distributors of drugs and pharmaceuticals in the state of Maharashtra and business owners looking to set up their businesses in Maharashtra are, apart from the central act, governed by the Maharashtra Drugs (Control) Act of 1960. The Food and Drug Administration (FDA) is the statutory body that regulates the licensing, administration, and overall functioning of entities engaged in the drug manufacturing and distribution business in the state of Maharashtra.
FDA intends to uphold and implement the provisions of the Drugs Act since it ensures that the drugs and pharmaceuticals are being manufactured with ethical processes, using approved, standard-quality raw materials, and do not cause any side-effect on the consumer’s health. Owing to a large number of incidences due to substandard and prohibited medications being circulated in the market, the manufacturers and distributors of medicinal drugs are required to submit details of the raw material and ingredients, products, manufacturing, packing, and labelling processes, a detailed outlay of the factory of the manufacturing plant where the drugs are manufacturing including information about machines and employees, possible side-effects and prescribed usage as per medical standards, etc.
Adherence to these regulations and guidelines is important since it concerns the health and safety of the consumers as well as the prescription opinion of doctors and hospitals that sell these drugs and medicines to their patients. Non-compliance with the provisions of the Drugs Act can lead to repercussions, including fines, imprisonment, and even cancellation of the drug license in Maharashtra.
Types of Durg Licenses in Maharashtra
Drug Licensing in Maharashtra is very activity-based compliance, which depends upon the type of activity undertaken by the manufacturer or distributor. For instance, if someone is manufacturing drugs, they require a manufacturing license; for selling the drugs to retailers or hospitals, they require a sales license. Similarly, for the purpose of letting any entity use or avail their drugs and medication, such as a druggist or a pharmacy, they are required to obtain a lending license from the FDA. Based on the category, salt, and quantity of drugs and pharmaceutical products produced, drug license in Maharashtra is divided into the following categories –
- Manufacturing License
This type of license is for the purpose of manufacturing drugs on a large scale for commercial purposes. It is the basic drug license in Maharashtra license required for the purpose of producing drugs and pharmaceuticals.
- Wholesaler License
It is a seller license that permits the sale of drugs and pharmaceuticals by wholesalers in bulk quantities to retailers and smaller corporations. A wholesaler license allows the sale of drugs in large quantities.
- Retail Drug License
Small sellers, suppliers, and distributors of drugs and pharmaceuticals who operate or wish to open up small set-ups such as drugstores, pharmacies, dispensaries etc. and sell the product directly to the end consumers.
Procedure for Obtaining a Drug License in Maharashtra
The Procedure for obtaining a Drug License in Maharashtra involves making an application with the FDA as well as the Central Drugs Standard Control Organization (CDSCO) in the prescribed form, accompanied by all relevant details and information about the applicant, drug, manufacturing process, and the manufacturing unit. After the examination and inspection of the documents provided to the authorities, the officials either approve the application and the Drug license is issued, or the application is resent to the applicant for clarification and rectifications on certain areas. The detailed Procedure for Obtaining a Drug License in Maharashtra is given below –
Step 1- Making an E-Application
The applicant shall proceed with making an account on the Xtended Indian Drugs Manufacturing Integration Node (XIDMIN) portal of the FDA Website. The applicant must log in by making a suitable ID and password.
Step 2- Uploading relevant Documents
After creating an account, the applicant shall proceed by uploading relevant application documents to the Portal.
Step 3- Paying the Government Fees
After uploading the documents required by the portal, the applicant shall pay the government fees for the application. The payment must be made using the Government Receipt Accounting System (GRAS) of the Mahakosh Portal of the Maharashtra government. The applicant shall specify the particular department, service, and license for which the fee is being paid, along with details of the factory and applicant address. After payment of the fees, the applicant must collect the Challan and note the transaction ID for further reference.
Step 4- Scrutiny by the Area Assistant Commissioner
After paying the requisite fee for a drug license in Maharashtra, the concerned area assistant manager scrutinizes the application, verifies all the details, and raises a query if he/she believes that there are some discrepancies. After rectifying the errors/inadequacies in the application, the applicant must resubmit the application.
Step 5-Allocation to Drug Inspector
After clearance from the Assistant Commissioner, the application is forwarded to the concerned Drug Inspector from CDSCO for further technical evaluation. After the evaluation is completed and he/she is satisfied with all necessary compliances, the Drug Inspector resends the application back to the Assistant Commissioner with their comments.
Step 6- Verification of Draft Licenses
Before issuing final copies of drug licenses, the licensing authority conducts one final verification of the application by scrutinizing all relevant details about the applicant and business. The application status can be seen and verified on the XIDMIN Portal of the FDA Website.
Step 7- Issue of Final Certificate
After clearing two stages of scrutiny, the licensing authority’s final decision, either granting or rejecting the application, is communicated to the applicant through e-mail. After the license is granted, the applicant can download the e-certificate from the portal, and the application process for obtaining a drug license in Maharashtra is completed.
Documents required for Pharmacy Registration in Maharashtra
To obtain a Drug manufacturing and distribution license and Pharmacy registration in Maharashtra, the following documents are required to be submitted for Pharmacy registration by the applicant to the regulatory authorities –
- A cover letter containing details about the company, categories of products, raw materials, prescribed dosage, and side effects of the drug.
- Application in Form 19 for retail license, Form 21 for wholesale license, and Form 25 for manufacture license.
- Fee payment receipts are generated by payment of fees through the GRAS Portal.
- Layout and site plan of the building with its name, address, scale of business, and measurements of the Area.
- Copies of Ownership proof of the manufacturing premises, such as Lease agreement, GSTIN number, and possession letter.
- Certificate of Consent to Establish (CTE) from Maharashtra Pollution Control Board.
- Details of Directors, Partners, Trustees, shareholders, and promoters of the company, along with CIN, DIN numbers, MOA, AOA, Company registration deed, partnership deed, etc.
Validity of a Drug License in Maharashtra
The validity of a drug license in Maharashtra is 5 years. The authorities can, anytime, conduct inspections and examinations of the factory premises to verify if the processes are being carried out in accordance with the guidelines of the Drugs Act. If they find that there are some discrepancies in the manufacturing processes, they can suspend or even cancel the License. The issued drug license is displayed on the FDA Website till it remains valid.
Drug License Fees in Maharashtra
Fees for obtaining a Drug License from the FDA vary depending upon the business activity of the person and license amount. Adding up the cost of submitting each individual document and form, the total fees for the drug license are calculated. To know about the exact fee structure depending upon your business activity, contact with the team of Corpbiz.
Effortless Drug Licensing: Corpbiz’s Expert Compliance Support
Keeping up with drug-related compliances can be a challenging task since it requires in-depth knowledge and expertise of various forms, filing procedures, and evaluation methods, includinginspection of the manufacturing unit by authorized officials. These documents should be drafted, executed, and submitted with precision andwithout any error since the FDA officials conduct a thorough examination of the documents and can resend the application if any discrepancies are found. Once rejected, an application needs to be re-submitted along with the fees.
At this point, you require an experienced compliance consultant to help you with your industrial licensing needs. Corpbiz is a trusted name in the domain of company incorporation and corporate advisory. With the assistance of our team of professionals, you can be assured of complete compliance solutions for your business venture without having to worry about leaving out any major licensing or compliance requirement.
Drugs and pharmaceuticals are two of the most crucial industries in a country, as they directly impact the health and lifestyles of innumerable citizens. It is for that reason that the Government keeps very strict measures and checks on the licenses and permits being given to manufacturers, distributors, suppliers, and other stakeholders of the industry. As a result, the nodal drug control agencies of the Government – Food and Drug Administration and the CDSCO Test License for Manufacturer monitor and regulate activities related to the manufacture and sale of drugs on state and central levels, respectively.
They are responsible for analysing each and every minute detail of the drug manufacturing process, from raw material to chemical compounds, labelling and packing of drugs, condition of manufacturing, and distribution. For this matter, they have set up a rigorous examination and evaluation process for the purpose of granting drug licenses in Maharashtra.
Frequently Asked Questions (FAQs)
The FDA, which stands for the Food and Drug Administration, is the nodal regulatory authority that grants licenses and regulates the functioning of drug and pharmaceutical manufacturers in the State of Maharashtra. It comes under the Ministry of Food and Drug Administration.
As per the Drugs and Cosmetics Act 1940, drugs are defined as “all medicines intended for external or interna; use for or in the treatment, diagnosis, mitigation, or prevention of disease or disorder in human beings or animals, and is manufactured as per the formulas described in, the authentic books of Ayurvedic, Siddha and Unani Tibb systems of medicine.”
The drug and pharmaceutical manufacturers and distributors in Maharashtra are governed by the Drugs and Cosmetics Act, 1940 and Rules,1945, and the Maharashtra Drug (Control) Act, 1960.
Based on the activity of the licensee’s activities and nature, drug license in Maharashtra is divided into three categories –
1. Manufacturing License
2. Wholesaler License
3. Retailer License
To apply for a drug license in Maharashtra, you need to submit an application with relevant documents while paying the requisite government fees. Moreover, the area assistant commission will review the application and then forward the application to the drug inspector before issuing the license.
A Drug license remains valid for 5 years, after which it is required to be renewed.
Documents such as a cover letter containing details about the company, categories of products, raw materials, prescribed dosage, and side effects of the drug, site Plan and layout of the building with name, address, scale, and measurements of the Area, copies of ownership proof of the manufacturing premises, such as Lease agreement, GSTIN number, and possession letter, etc. shall be required for filing a drug license application.
After submission of the documents, the FDA and other authorities take about 45-60 days for examination and scrutiny, after which the license is issued.
The fees for drug licenses vary depending upon the type of license sought – a manufacturer license is Rs. 39,999/-, a wholesaler license is Rs. 99,999/-, and a retailer license is Rs. 49,999/-. Apart from the Government fee, the applicant is also required to pay applicable GST on each category of form.
The drug license fees are paid through the Government Receipt Accounting System (GRAS) portal of the Mahakosh website of the Maharashtra government.
A drugs license in Maharashtra remains valid for a period of 5 years from issuance.
Yes, a drug license is required if someone wants to import drugs from a foreign country in India.
Corpbiz is a trusted name in the domain of company incorporation and corporate advisory. Our experts will keep you assured of complete compliance solutions for your business venture without having to worry about leaving out any major licensing or compliance requirements.
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