In 1940, Parliament passed the Drugs and Cosmetics Act, which governs the import, production, and distribution of drugs throughout the country. The main objective of the Act is to make sure that all drugs and cosmetics marketed in India are secure, efficient, and up to par with international standards.
The related Drugs and Cosmetics Rules, 1945 provides rules for classifying medications into Schedules as well as instructions for each category's storage, sale, presentation and prescription.
At present, the Second Schedule of the Act only recognizes legally binding standards for drugs, so there are no standards for medical devices and no way to prosecute a manufacturer of medical devices. The Act does have penalty provisions for the manufacture of sub-standard drugs, but these cannot be used to punish manufacturers of sub-standard medical equipment.
The system still has shortcomings that need to be addressed. Considering the above issues, the new Drugs, Medical Devices and Cosmetics Bill, 2022 is envisioned to oust the 1940 Act. The primary aim of the new Bill is to facilitate a proper channel to accommodate the adoption of new technology. In a recently released draft of the Bill, the Ministry of Health and Family Welfare (MoHFW) revealed its intention to amend and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics to ensure their quality, safety, efficacy, performance; and clinical trial of new drugs and clinical investigation of medical devices.
The National Institute for Transforming India (NITI) Aayog cited three reasons to establish a separate law for medical devices:
The Drugs and Cosmetics Act of 1940 is outdated; therefore, it cannot regulate medical devices in a healthy way;
Lack of human expertise in the Central Drugs Standard Control Organisation (CDSCO) to check the safety and efficacy of medical devices; the professionals in the CDCSO have chemical-based knowledge that only applies to pharmaceuticals and lack the knowledge of the complicated electronic technology that comes with some medical devices;
Due to a lack of resources to check the quality of devices, they proposed only regulating Category A devices like pacemakers that are intrusive and fit inside the human body.
In response to the said proposal to implement new regulating laws, a notice had been issued to notify all medical devices under sub-section (b) of Section 3 of the Drugs and Cosmetics Act, 1940 to regulate them under the terms streamlined in the said Act and the Medical Devices Rules, 2017. Some of the penalties for placing a device on the market without a valid certificate of conformity include:
Fines up to ₹50 lakh
Up to 3 years of jail time
Other monetary fines on the manufacturers or importers of unsafe medical devices.
Despite such laws passed, the Central government recommended and felt the need to have clearer and more comprehensive legislation, and so a committee was constituted for framing the new Drugs, Cosmetics, and Medical Devices Bill. With emphasis being placed on reviewing obsolete laws and “periodically repealing and amending laws”, the Bill had been proposed before Parliament.
Johnson and Johnson’s faulty hip implants case
In 2018, Johnson and Johnson’s hip implant called ASR was found to be leaking cobalt-chromium ions into the body which leads to fatal health complications, including metal poisoning of the blood, debilitating pain, and damage to organs. J&J has paid compensation to patients in the United States who had received defective implants. However, in India, the company has challenged government orders to compensate 4,700 patients who had undergone hip replacement surgeries.
The problem with the settlement is that the patients, who are the most important stakeholders, are not parties to this litigation. One of the fundamental tenets of law is that no order, not even one that is perceived to be a favourable order, should be passed by a court of law without hearing the parties who are going to be impacted by the order.
The lawyers would have also informed the Court that J&J has knowledge of at least 254 patients who have had revision surgery as per the expert committee report. Why then is J&J prepared to pay only 67 patients? What of the remaining 3,600 patients who have not been informed of the problems with the implant? In this way, J&J continues to exploit the regulatory deficit in India.
The shortcomings of the Drugs and Cosmetics Act, 1940 exposed a toothless regulatory framework for medical devices. The executive cannot create new offences or penalties through its rule-making authority. Only laws enacted by Parliament can create new offences and penalties. As a result, the Medical Device Rules, 2017 contain no penal provisions. The legally binding standards recognized under the Second Schedule to the 1940 Act covers only pharmacopoeias for drugs, and no standards for medical devices, and therefore, no prosecution of a manufacturer of sub-standard medical devices.
There are no tools available to Indian regulators under the framework to hold makers of sub-standard medical device manufacturers to account for their actions. At most, the Health Ministry can prohibit the manufacture and sale of certain medical devices under Section 26A or cancel a license to prevent further harm.
In the J&J case, the manufacturer sold devices to doctors and hospitals instead of patients directly, so it did not have a list of patients who had these devices implanted. Doctors and hospitals lack incentives to share the patient list and even if they want to, legal liability for surgically faulty devices in the patient’s body would stop them from doing so.
Problems addressed by the 2022 Bill, and shortcomings
In Chapter II of the draft, the Ministry has made a provision for the creation of a medical devices technical advisory board. This board will include medical professionals and people with technical knowledge of the devices. Officials from the Health Ministry, Department of Atomic Energy, Department of Science and Technology, Ministry of Electronics, Defence Research and Development Organisation (DRDO) and experts in the field of biomedical technology, biomaterials and polymer technology will be part of the board. At present, the decisions regarding medical devices are taken by the drugs technical advisory board. The Bill also proposes medical device testing centres on the lines of drug laboratories in states and at the Central level.
In Chapter VI of the draft, regulations for medical devices, investigational medical devices, clinical trials of investigational medical devices, etc have been mentioned. In the interest of public health or extreme emergency of medical devices, the Central government is empowered to waive the requirement of conducting a clinical investigation to manufacture or import a new medical device into the country. Like drug clinical trials, medical management and compensation have to be provided to persons who are injured while participating in such an investigation.
However, the definition of ‘clinical trial’ in Section 1(k) of the draft bill is vague. It deviates considerably from the World Health Organisation (WHO) definition of clinical trial.
The draft recognizes the issues of e-pharmacies and provides that the Union government can come up with rules and regulations to regulate the online sale of drugs. It mentions that “no person shall himself or by any other person on his behalf sell, or stock, exhibit, offer for sale, or distribute, any drug by online mode except under and in accordance with a license or permission issued in such manner as may be prescribed.” It also prohibits such sales in the category of medical devices.
At the end of the draft, the First Schedule mentions standards to be compiled with by drugs manufacturers for sale, stock, exhibition for sale or distribution of imported drugs. The Second Schedule mentions the fee payable for license, permission, registration certificate and approval.
The term “some innocuous substance or ingredient” in Section 44(2)(a) needs elaboration. It is too ambiguous and imprecise.
Section 73(3) provides a vague explanation and needs to be tangible on the compensation – the exact amount of the compensation should be fixed.
Section 104 provides a detailed explanation of punishments for sellers of spurious allopathy and AYUSH drugs, but they fail to consider them as identical, as both are playing with the safety and lives of humans.
Law is organic and is constantly amended to improve and facilitate the smooth flow of regulation, and to provide fair compensation to victims. A scientific and sophisticated technological process needs to be put in place in case a drug needs to be recalled urgently for the safety of the patients. There are examples of such incidents in the present century with drugs such as cerivastatin, rofecoxib and cisapride to name a few.
There is no mention of the need to standardize AYUSH products, which is an absolute necessity. Along the lines of the National Institute of Pharmaceutical Education and Research (NIPER), we should have specialized institutes to educate students on quality control, quality assurance, and WHO-Good manufacturing practices. Like many other countries, India too should not allow any company to market pharma products, unless they have their own manufacturing units. There is a need to revisit this Bill of 2022 in light of the above challenges and issues.
Nabeela Siddiqui Assistant Professor & Research Scholar, School of Law, CHRIST (Deemed to be University) NCR Campus.