The healthcare and medical device sectors in India have grown appreciably in the last decade. India is said to be known as indigenous medical device industry which is valued at 250 crores and contributing to only 6% of India’s total healthcare sector. The Indian medical device industry is Asia’s 4th largest and medical technology sector in India is projected to reach US$ 50 billion by 2025 and currently pegged at US$ 10 billion.
The current regulatory structure is blemished by barriers such as lack of regulatory environment, rules or regulations & guidelines, low penetration, high capital investment and lack of active participation from the government. Hence, regulatory bodies have acknowledged the need to frame guidelines & regulatory approval processes and for quality benchmark on par with global standards.
In July 2022, the Ministry of Health and Family Welfare released a draft of the Drugs, Medical Devices and Cosmetics Bill, 2022 (“the bill”) with an aim of reviewing, replacing and modernizing the obsolescent Drugs and Cosmetics Act, 1940 where the ministry has been persistently reviewing and streamlining the rules to further accommodate the changes and to adopt the new technology. The Ministry of Health and Family Welfare formed an 8-member committee headed by Drug Controller General of India, Mr. V.G. Somani for framing the draft bill, which is now put on the website of the ministry for recommendations and suggestions from public in general and stakeholders.
As the Ministry of Health and Family Welfare has not yet introduced new rules to be on par with the provisions of the modernised Bill. A transitory provision has been added to the bill that states that until new standards are established, the rules listed in the 9th Schedule, which include the Drugs Rules of 1945, Medical Devices Rules of 2017, New Drugs and Clinical Trials Rules of 2019, and Cosmetics Rules of 2020, shall remain in effect.
OBJECTIVE OF THE BILL
The aim of the bill is to ensure and provide comprehensive legislation to regulate that the medical products sold in India are safe, effective and conform to prescribed quality standards to the individuals. The other objectives are enumerated as under:
- To amend and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics
- To ensure the quality, safety, efficacy, performance and clinical trial of new drugs and clinical investigation of investigational medical devices
- To ensure that drugs, cosmetics and medical devices sold in India are reliable, efficient, and conform to quality requirements
- To adapt to the modern-day technological and medicinal breakthroughs
- To boost domestic manufacturing of medical devices and attract huge investments in India in healthcare center.
GIANT EXPECTATIONS FROM DRAFT BILL
The regulation of all retail channels as proposed in the bill becomes even more determining, after recent raids by the Special Task Force (STF) in Uttarakhand resulted in the seizure of fake drugs worth of crores, which are:
- The bill has expanded to include and regulate e-pharmacies, medical devices and the conduct of clinical trials of drugs and medical devices. It also includes a section on Ayurveda, Siddha, Sowa Rigpa, Unani and Homeopathy drugs.
- During Pandemic, the increasing online sale of medicines and medical devices which will now get restricted i.e. the sale, stocking, distribution or exhibition of any drug by online mode (e-pharmacy) except under and in accordance with a licence or permission.
The WHO declared monkeypox as a public health emergency of international concern, one level below a pandemic, even as COVID cases once again surged past the daily 1000 mark in some states of India. The bill will have to carefully balance these headwinds facing the healthcare sector and protecting interests of the society at large.
KEY DEFINITIONS OF THE BILL
This Bill which is an exaltation of the Principal Act, 1940 introduces provisions for clinical trials and regulation of medical devices. This has been welcomed by the industry as it effectively addresses the problems plaguing the healthcare industry in India and is an improvement on the current regulations, which is imprecise and has done more harm than good. The key definitions introduced under the bill are given as under:
- Clinical Trial means any systematic study of new drug or investigational new drug or bioavailability or bioequivalence study of any new drug in human participants to generate data for discovering or verifying its clinical, pharmacological, including pharmacodynamic and pharmacokinetic, or adverse effects with the objective of determining safety, efficacy or tolerance of the drug.
- Over-the-counter Drugs means drugs that can be sold by way of retail to a consumer without prescription from a registered medical practitioner as per the conditions and in such manner as may be prescribed.
- Investigational New Drug new chemical or biological entity or substance which is under investigation in a clinical trial regarding its safety, tolerance and efficacy.
- Proprietary Medicine means a drug which is a remedy or prescription presented in a form ready for internal or external administration on human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being in force or any other Pharmacopoeia authorized in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board.
- Ayurveda, Siddha, Sowa Rigpa or Unani or Drug means all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in, the authoritative books of Ayurvedic, Siddha, Sowa Rigpa and Unani Tibb systems of medicine.
KEY HIGHLIGHTS OF THE BILL
Some of the key regulations proposed in this Bill include:
- ONLINE PHARMACIES: The Bill has for the first time introduced a regulatory mechanism for online sale of drugs and cosmetics, making it mandatory for every person who stocks, exhibits, sells or distributes any drugs through online mode to obtain a license or permission from the Authority, though there are no clear guidelines on the procedures for acquiring license, nonetheless Section 83(2)(l) mentions that Central government would makes rules prescribing the manner for regulation and restriction for online mode of sale of medicines.
- MEDICAL DEVICES:
- Today millions of patients depend on medical device based treatment for the management and diagnose of several diseases. Quality and safety of device is depends upon the regulatory guidelines.
- The Bill establishes a distinct definition for medical devices. The Bill also proposes to constitute a separate Medical Devices Technical Advisory Board to advise the government on technical matters pertaining to medical devices, which shall include officials from the various Government Departments and experts nominated by the government from the field of medical devices industry.
- The Bill prohibits the manufacture, import, or distribution of medical devices that are not in conformity with the prescribed standards of quality, safety, and performance. And makes it mandatory to obtain permission from the Central Licensing Authority for conducting any clinical investigation of medical devices on human participants.
- Furthermore, provisions relating to compensation and medical treatment in case of injury or death of a person participating in clinical investigation of any investigational medical device have been provided. It also allows the Central Licensing Authority to waive the requirement of conducting clinical investigation for manufacture or import of a new medical device in public interest.
- AYUSH PRODUCTS: The current Drugs and Cosmetics Act only regulates Ayurveda, Unani, and Siddha drugs and cosmetics, the bill proposes to include and regulate Sowa Rigpa, Homeopathy, and Traditional Medicines as Ayush Products.
The Bill proposes to constitute an Ayurveda, Siddha, Sowa-Rigpa, Unani, and Homeopathy Drugs, Medical Devices, and Cosmetics Consultative Committee to advice both the State and Central Government with the aim of securing uniformity throughout India for regulation of AYUSH Drugs, Medical Devices, and Cosmetics.
- CLINICAL TRIALS AND INVESTIGATIONS: For the first-time provisions relating to the clinical trials have been included under the Bill, which prohibits the conduct of a clinical trial of a new drug, investigational new drug, bioavailability or bioequivalence study of any new drug in human participants without obtaining permission from the Central Licensing Authority. Furthermore, provisions relating to compensation and medical treatment in case of injury or death of a person participating in a clinical trial or study of such a drug are also included.
The proposed bill has replicated next to all the offences of the existing Drugs and Cosmetics Act; however, in order to make the punishments more stringent the bill enhances the period of imprisonment between 1-10 years which may extend to life imprisonment and amount of fine up to Rs. 15 lakhs for any contravention of provisions of the bill. Additionally, the Bill introduces penalty provisions for clinical trial and clinical investigation without permission, and for failure to provide compensation for injury or death related to clinical trial.
The bill proposed to create the independent authorities & boards to take decisions on the regulation of medical devices. The important comparative move under the new bill is as under:
|PARTICULARS||THE DRUGS, MEDICAL DEVICES AND COSMETICS BILL 2022||DRUGS AND COSMETICS ACT, 1940|
|Constitution of Technical Advisory Board State drugs laboratories and State medical devices testing centers.||Advisory Boards for Drugs and Medical Devices are to be constituted separately State Drug Laboratories and Medical Devices Testing Centers are to be constituted.||Single Drugs Technical Advisory Board is constituted Provisions for states to establish drug laboratories for testing not covered under the 1940 Act or 1945 Rules.|
|Prohibition of import of certain cosmetics||Prohibits import of cosmetics which is not of standard quality, or is misbranded, adulterated or spurious.||No such provision for prohibition of import of adulterated Cosmetics prescribed in the Act|
|Prohibition of online sale of Drugs and Cosmetics.||Prohibition on Sale of drugs and cosmetics through online mode without obtaining license||The Act does not regulate online sale of drugs and cosmetics.|
|Prohibition of manufacturing of New Drug.||Prohibition on manufacturing of any new drug without obtaining license||No such restriction prescribed in the 1940 Act.|
|Police to assist Drugs Control Officer.||Police officer to assist Drugs Control Officer demanding his assistance in the investigation and preventing the escape of suspected offenders||No equivalent provision under 1940 Act.|
|Scientific Research Board||Scientific Research Board to be established to support the regulatory authority on the scientific advances used for developing, innovative Drug of Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy||No Such Research board has been established under the Act|
The Proposed Legislation is the first step forward in reforming India’s current method of drug and cosmetic regulation and revamp of Drugs and Cosmetics Act is a welcome move and has been long overdue. As there was need to have comprehensive legislation for accommodating and adapting to new requirements of modern technology in the healthcare sector, despite the reiteration of the old law, the Bill’s insertions, omissions, and goal are expected to improve quality, consumer confidence, and stakeholder expectations. The Draft Bill is primarily concerned with regulating medical devices as a distinct category.
It also acknowledges the role of independent governing authorities with medical device technical knowledge. The Draft Bill is ideal for the industry in this regard, as there was a need for regulation on E-Pharmacies, Clinical Trials and Investigations along with stringent penalties to fill the existing gaps in the healthcare laws and regulations.