Registration of medicines and medical devices is an indispensable requirement for the manufacturing and usage of medicines and medical devices in India. The proper identification of the medicines and providing the requirements for their safe use are the main goals of drug registration. Enforcement measures and proper guidelines can be instituted upon the manufacturers and users of these drugs and devices only when there is a statutory obligation behind it to do so. The rules and guidelines specified under these Acts play a major role in the proper use of consumption of drugs and medical devices.
Laws governing Medicines in India:
- Drugs and Cosmetics Act, 1940: The Drugs and Cosmetics Act, of 1940 regulates the import, manufacture, and distribution of drugs as well as medical devices in India. The primary objective of the enactment of the Drugs and Cosmetics Act, of 1940 is to ensure that the drugs and cosmetics sold in India are safe, effective, and conform to state quality standards.
- Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954: The legislative intent in devising the Drugs and Magic Remedies (Objectionable Advertisements) Act is to control the advertising of drugs in India. It prohibits advertisements of drugs and remedies that claim to have magical properties and indulging in such advertisements of drugs is claimed to be an offense under this Act.
- Pharmacy Act, 1940 (Rules by the Pharmacy Council of India): The Pharmacy Act was brought in to regulate the profession of pharmacy and to constitute pharmacy councils. For the purpose of registering as a pharmacist under the Pharmacy Act, the country’s pharmacy education is regulated. Regulation of Pharmacy Practice and maintaining pharmacy as a profession is the core objective of this Act.
- Guidelines under Central Drug Standard Control Organisation (CDSCO): Under the Drugs and Cosmetics Act, CDSCO is answerable for the approval of New Drugs, Conduct of Clinical Trials, laying down the requirements for Drugs, manage over the high-satisfactory of imported Drugs, and coordinating the sports of State Drug Control Organizations with the aid of using imparting professional recommendation on the way to result in the uniformity within side the enforcement of the Drugs and Cosmetics Act.
CDSCO together with kingdom regulators is mutually answerable for providing licenses of positive specialized classes of important Drugs which include blood and blood products, I. V. Fluids, Vaccine, and Sera.
Laws Governing Medical Devices in India:
- Drugs and Cosmetics Act, 1940
The statute framing the rules for manufacturing medical devices is the Drugs and Cosmetics Act, 1940. The notification of devices through this Act is very much essential to carry out their usage.
- Medical Devices Rules, 2017
The Licensing Application process for medical devices in India is being carried out by these rules and it is applicable to in-vitro diagnostic medical devices. The latest amendment to these rules were brought in 2020.
Process involved in the registration of medicines in India
- Submission of Documents: To prevent persons from abusing or misusing such products, access to medications and drugs must be controlled and restricted. As a result, the Pharmaceuticals and Cosmetics Act of 1940 makes it mandatory for all pharmacists, distributors, retailers, producers, sellers, dealers, and importers of drugs, cosmetics, and Ayurveda, Siddha, and Unani drugs to get drug licenses. These licenses are issued in the form of certificates. The following documents must be enhanced for the purpose of registering the medicines in India, which includes;
- MOA and AOA
- ID proof of the partner/director/promoter
- Copy of ownership documents of properties along with site plan of the premises for manufacturing of the medicines.
- Copy of board resolution permitting the grant of license.
- Proof that storage capacity is available, including cold storage, a refrigerator, etc.
- Copy of challan as evidence of fee deposit
- Affidavit regarding the firm and its owner, partners, and directors not being convicted.
- Cover letter with the name of the applicant
- Declaration form
- Applicant’s qualification certificate
- Approval from DCGI: Once after submitting all the necessary documents, the verification would be done by the Drug Controller General of India. If the DCGI is satisfied, then the approval certificate will be issued.
Process involved in the registration of medical devices in India
- Submission of Documents: Before submitting the application for registration, it is necessary to check whether the product requires registration and an authorized Indian agent must be appointed. The following particulars must be provided for registering medical devices in India which includes;
- The application form as specified under form 40 of the drugs and cosmetics rules, 1945 must be submitted along with the Power of Attorney, Schedule D(0), ISO 13485 Certificate, Full Quality Assurance Certificate, CE Design Certificate Declaration of Conformity, Free Sale Certificate, Certificate of Marketability from GHTF countries and other Regulatory Approvals, PMS report, Plant Master File and Device Master File.
- Registration certificate as specified under form 41.
- Importing license as specified under form 10.
- ISO Certification: It is mandatory for all medical device manufacturers to get the ISO certification from the National Accreditation Board for Certification Bodies (NABCB) or the International Accreditation Forum (IAF) to the manufacturer of medical devices which is based on the quality management system of the medical device.
This sets out the entire process behind the entry of medicine and medical device into the market and its functioning which is a significant guide for all the users and the associated persons involved in it. Hence, proper statutory enforcement has to be given to the procedural aspects for building up the healthy pharmaceutical sector.
Intern at Aggarwals & Associates, S.A.S. Nagar, Mohali