Laws Regulating Drugs and Medical Devices :Mr. Ricky Chopra
www.rcic.in.
Introduction India has the 4th largest market for drugs and medical devices in Asia. The industry has been predicted to grow to be a $ 50 billion industry in less than 5 years by 2025. Not only this, Serum Institute of India is the largest manufacturer of vaccines in terms of capacity. Evidently, an industry with such a large potential is unlikely to be left unregulated by the legislature. As a result, there is a nuanced regulatory framework in India to govern the production, marketing, distribution and use of all kinds of medical devices and drugs. The central umbrella legislation for the same is the Drugs and Cosmetics Act, 1940. All surrounding legislations, like the Drugs and Cosmetics Rules, 1945 have been formulated by virtue of powers vested in the Central Government under the Act of 1940. The Ministry of Health and Family Welfareis the nodal agency under the Central government which oversees the eective implementation of these regulations.
The Drugs and Cosmetics Act, 1940 This is the umbrella legislation which deals with regulation of drugs and medical devices in India. It is from Section 12 of this Act that the Central Government derives the power to make rules and as a result the Drugs and Cosmetics Rules, 1945 were formulated. Section 5 of the Act gives www.rcic.in.
power to the Central Government to constitute a Drugs Technical Advisory Board (DTAB) which shall be responsible for assisting both the Central as well as the State Governments for technical matters in implementation of the Act and the rules. The second schedule to the Act prescribes standard quality to which drugs must comply in order to be fit for the Indian market. Section 10 of the Act imposes a restriction on import of drugs which are not of standard quality, drugs which are spurious, adulterated and misbranded. The Act provides for Inspectors under Section 21 and mentions that they shall be deemed to be public servants. They have powers to enter any premises, stop any vehicle, take any sample for testing, call for record of any documents, register etc. The Act also has a special section, Chapter IV-A dedicated exclusively for Ayurvedic, Siddha and Unani medicines. Most importantly, the Act provides for contraventions. Section 27 of the Act provides any person who is breach of conditions relating to manufacture, sale or distribution of the drugs or engages in any of these activities without a valid license shall be liable for imprisonment for a period not less than 10 years along with a fine of amount not less than 10 lakh rupees or three time the value of the drugs confiscated, whichever is higher. However, Section 32B also gives a respite in the form of option for compounding of less grave offences by payment of credit to the Central or the State Government as the case may be. Lastly, Section 36AE entitles the wrongdoer to prefer an appeal to the concerned High Court. Section 36 AD also states that for the purposes of this Act, the Special Courts constituted thereunder shall be deemed to be Court of Sessions under the Code of Criminal procedure, 1973 and shall have all the powers vested in such criminal courts. www.rcic.in.
The Drugs and Cosmetics Rules, 1945 Contrary to the brief and succinct Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945 are much more detailed and nuanced. They provide guidelines for each and every aspect of drugs and devices, ranging from their manufacture, import, development of drugs, their packing storage, and labelling, to the procedure for clinical trials for vaccines. The rules provide for a Central Licensing Authority, which post shall be held by the Drugs Controller general of India (DCGI). It is the nodal authority for approvals and authorizations under the rules. The DCGI is a part of the Central Drugs Standard Controls Organisation (CDSCO). It provides for the constitution of a Central Drugs laboratory which shall be vested with the power to test samples for evaluating their suitability for grant of license for manufacturing etc. Schedule X of the rules lay out the detailed procedure for import of drugs and Schedule Y of the Act lays out a detailed framework for clinical trials for drugs. The framework provides for manner of application, the eligibility criteria, the fee for licenses, conditions for granting of the license, the time periods for the procedure, and appeals in case the entities are not satisďŹ ed with the decision of the licensing authority etc. The Rules also provide for import and storage of homeopathic medicines. It provides the standards for use not just for humans but also those used for veterinary purposes. The drugs regulated under the Act and the rules cover all kinds of drugs whether used for prevention, diagnosis or treatment of a disease or disorder. www.rcic.in.
The Medical Devices Rules, 2017 The Medical devices Rules, 2017 provide for four categories of medical devices- Class A, B, C and D devices. Class A medical devices are low risk devices, Class B devices are low to moderate risk devices, Class C devices are moderate to high risk devices and Class D devices are high risk devices. The Act provides for granting registrations and licenses for testing, manufacturing, import, sale, distribution, stocking or offer for selling the classified medical devices, testing clinical performance of medical devices etc. The medical devices are required to conform to the standards set by the Bureau of Indian Standards under Section 3 of the Bureau of Indian Standards Act, 1985. Just like the Drugs and Cosmetics Act had inspectors, the Medical Devices Rules, 2017 have Medical Device Testing officers. They have the authority to seize documents, confiscate medical devices, test and evaluate the sample of medical device that has been sent to them etc. Recently, the Medical Devices (Amendment) Rules, 2020 were also notified with a newly incorporated chapter that talks about those medical devices that are required to be registered and about the procedure to procure the approval under the original rules.
www.rcic.in.
Recent Developments On February 11, 2020 the Ministry of Health and family Welfare issued a notification, bringing medical devices within the definition of “drugs” under the Drugs and Medical Devices Act, 1940. It also overhauled the definition of drugs under section 3 (b) (iv) of the Drugs Cosmetics Act, 1940 to give effect to the amendment notification. Additionally, registration of all kinds of drugs has been mandatory. Prior to this, it was unclear for which drugs registration was mandatory and for which it wasn’t mandatory. The new rules also prescribe that all medical devices henceforth manufactured must comply with the ISO standard 13485. These changes were brought about after a well thought out decision and consultation with the public by virtue of draft rules which were circulated in October 2019. Moreover, enough time has been given for medical devices to be registered, that is, a time period of 18 months has been given from the date of notification. While new devices may get their license and registration as an when they are produced, the existing devices which were exempt from registration under the erstwhile regulations have time until July 2021 to get their devices registered. As far as manufacturers, importers and sellers of medical devices are concerned, a breathing period of 30 months has been given by way of exemption from registration for Class A and B devices, a period of 40 months for Class C and D devices.
www.rcic.in.
Ricky Chopra International Counsels’ Practice in the Medical Devices Sector Ricky Chopra International Counsels is a leading full-service law firm in India with a specialized practice area dedicated to the medical sector. Our experienced group of lawyers have several years of experience in giving cutting edge to advice to our clients in the medical sector, both in India as well as globally. Senior leaders of the firm have experience of appearing before a variety of tribunals and regulatory authorities including the CDSCO. Whether it is procuring a license for manufacturing a drug, approval for clinical trials for developing a potential vaccine or getting sanctions for importing a drug for sale in India, our team can assist you in every leg of the process.
Conclusion The amendments brought about in 2020 have certainly been salutary. They not only bring about the much needed clarity in respect of registration for medical devices, but by making registration for every medical device mandatory, it has benefitted the consumers as manufacturers and distributors will have to keep a check on the quality of their products. The provision for proper display of date of manufacture, import and expiry on the label also assists the consumers in determining whether the particular device is safe for their use or not.
www.rcic.in.
With the onset of the COVID-19 pandemic and other emerging bacteria and viruses, the pharmaceutical sector has come to become one of the most crucial sectors aecting the population directly. To leave the matters to State Government or to the stakeholders themselves for self-regulation wouldn’t prove to be a viable solution. Therefore, the amendments have come about in a timely manner to make India well-equipped to deal with future challenges in the medical industry.
Offices
Chandigarh New York
Gurugram New-Delhi
www.rcic.in.