Introduction: Medical Drugs and Medical Devices

In India, regulation of medical devices and drugs is supervised by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare to guarantee their safety, effectiveness and quality. Form MD-41 is mandatory for manufacturing or importing C and D Class medical devices classified as medium or high risk in compliance with the Medical Devices Rules, 2017. In the meantime, Forms MD-19, MD-20B, and MD-21B are required for licensing the manufacture and wholesale distribution of pharmaceutical drugs. These licensing forms help maintain stringent regulatory oversight and confirm that only accredited and qualified entities are involved in the manufacturing, distribution and sale of medical products in India.

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Medical Device Licensing form MD-41

As per the recent changes brought in the Legislature through which separate licensing is required to be done for the Medical Device wholesalers in Medical Device Licensing form MD-41 through the Director-general of Health Services. As per the Central Drugs Standard Control Organisation the importer or Manufacturers of Class A and Class B medical Devices, have to submit the application to the Central Licensing Authority before coming into force of the amended provisions of Medical Devices rules, 2017. The government has granted 6 months time period from the Effectiveness of a new amended Compulsory Device Licensing form MD41, through the 87A introduced in the 2017 rules, which is implemented for Class A and Class B Medical devices which are considered very low-risk devices, permission shall be granted by the State Licensing Authority. There are two more categories of medical devices that are Class C and Class D which are categorized as very high-risk category Devices, the licenses of the devices of these categories are granted by the Central Licensing Authority.

Documents to be Uploaded Along With The Application Form of Device Licensing Form MD-41

• ISO 13485 Certificate.
• TR6 Challan.
• Cover Letter (Describing your experience and skills).
• Challan fees (copy).
• Memorandum of association and Article of Association (proof of Constitution of the firm).
• Declaration of Managing Director(s)/Proprietor/ Partners.
• List of all the Directors/Partners with age & complete postal & residential.
• Address.
• Documents of ownership or Tenancy agreement.
• Plant Master File

Following Documents Should Also be Submitted.

• Id proof (Aadhar card, PAN card, etc)
• Declaration of Analytical Chemist.
• Declaration of Manufacturing Chemist.
• Documents of educational qualification, experience, and approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters.
• Registration from District Industries Centre. 

Medical Drug Licensing Form MD-19/20B/21B

For the sale and distribution of Wholesale drugs by a business or Startup, a wholesale drug license in forms 20, 21, 20B, and 21B is required.  It is made mandatory through the regulation for granting a Wholesale License. It is governed by the Drugs and Cosmetics Act, of 1940.

This is required for manufacturing pharmaceuticals, sale, distribution, or storage of the medication. Through the license you prove yourself as an authorized person with an authorized business for manufacturing and distributing pharmaceuticals, it is illegal to manufacture drugs in India without registration.

The government has complete control and authority to regulate the import and export of medicine, and head to regulate the Consumption of Schedule H & X drugs, etc.  

Once the license is granted, its validity remains perpetual or till the suspension of the same through the Drug Inspector, for the retention of the license the licensor needs to pay Rs. 3000 as a retainer fee. 

Documents To Be Uploaded Along With The Application Form Of Licensing Form MD-19/20B/21B:

• ISO 13485: 2016 Certificate
• TR6 Challan.
• Cover Letter (Describing your experience and skills).
• Application Form (along with Proof of qualification, Registration Certificate of Chemist/Experience certificate, and appointment letter).
• Challan fees (copy).
• Memorandum of association and Article of Association (proof of Constitution of the firm).
• Declaration of Managing Director(s)/Proprietor/ Partners.
• List of all the Directors/Partners with age & complete postal & residential address.
• Documents of ownership or Tenancy agreement.
• Plant Master File.

Following Documents Should Also Be Submitted:

• Id proof (Aadhar card, PAN card, etc)
• Proof of drug storage at the site.
• Declaration of Analytical Chemist.
• Declaration of Manufacturing Chemist.
• Documents of educational qualification, experience, and approval certificates of proposed Manufacturing Chemist & Analytical Chemist; Appointment Letters.
• Registration from District Industries Centre. 

Conclusion

In conclusion, the Medical Devices Rules, 2017 and the Drugs and Cosmetics Act, 1940 establish a structured regulatory system for medical devices and drugs in India. The form MD-41 is used to license the manufacture and import of medical devices, depending on their risk classification, thereby confirming proper monitoring either by the state or central licensing authorities. Additionally, the license for wholesaling and distribution of medicines requires Form MD-19, 20B and 21B, which confirms that only authorized institutions can operate in the sector. The extensive documentation essential for both device and drug licensing highlights the government's prominence on quality, safety, and regulatory compliance, which ultimately safeguard public health and ensure effective health care delivery.