The Union Health Ministry of India recently unveiled a draft of the proposed Drugs, Medical Devices and Cosmetics Bill, 2022. This new proposed bill is set to replace the current legislation, the Drugs and Cosmetics Act, 1940. The aim of this bill is to introduce separate regulations for medical devices. It also includes provisions for fines and jail terms for injuries and deaths associated with clinical trials or investigations. Furthermore, it seeks to bring e-pharmacies under regulatory purview.
Understanding Medical Devices
The medical device industry is a unique convergence of engineering and medicine. This sector focuses on creating life-supporting machinery to be used inside the human body. This broad category includes surgical equipment, diagnostic tools such as cardiac imaging, CT scans, X-rays, molecular imaging, MRI scanners, and ultrasound-imaging devices. Additionally, life support equipment such as ventilators, implants, and disposables also fall into this category.
Key Highlights of the Draft Bill
The proposed bill is marked by several significant provisions. These are pertaining to clinical trials and investigations, compensation to heirs, penalties, fines, prohibitions, and the formation of a Medical Devices Technical Advisory Board.
The draft bill mandates compensation to participants or their legal heirs in case of injury or death caused during clinical trials and investigations for drugs and medical devices. It also states that investigators must provide medical management for any injury resulting from the trial.
Additionally, the draft outlines penalties and fines amounting to double the compensation amount if the compensation remains unpaid. It also prohibits clinical trials or investigations of drugs and medical devices without permission from the relevant licensing authority. Investigators and sponsors who violate these provisions could face debarment.
One key highlight of the draft bill is the creation of a Medical Devices Technical Advisory Board. This board, similar to the existing drugs technical advisory board, will comprise of industry experts with technical knowledge about these devices.
Issues Addressed in the Draft Bill
The draft also tackles the issue of e-pharmacy and its role in violating existing regulations. Currently, there are barely any provisions for regulating online pharmacies in the 1940 legislation. Most of the operating e-pharmacies work outside the boundaries of law, often holding licenses for physical shops or storage units, and delivering medicines without prescriptions, making it difficult for regulatory authorities to take action against them.
Current Status of Medical Devices Industry in India
India’s medical devices industry is a burgeoning sector. Its current market size is estimated at USD 11 billion and comprises both large multinationals and small and medium enterprises (SMEs). The industry has been growing steadily at an annual rate of 15% over the last three years and is projected to reach USD 50 billion by 2025. Foreign Direct Investment (FDI) is allowed at 100% under the automatic route for both brownfield and greenfield setups, reflecting the confidence of global players in the Indian market.
To encourage local manufacturing, the government has initiated several schemes such as the Production Linked Incentive Scheme and the Promotion of Medical Device Parks. Both initiatives aim to strengthen the infrastructure base and develop a robust manufacturing ecosystem for medical devices in the domestic market.
The Need for this Bill
Currently, around 80% of medical devices sold in India are imported, especially high-end devices. Indian companies primarily focus on low-cost and low-tech products like consumables and disposables, leading to a more substantial value share going to foreign companies.
The proposed bill aims to reduce India’s import dependence from 80% to nearly 30% in the next decade, and position the country as one of the top five global manufacturing hubs for medical devices by 2047. It also targets to increase India’s per capita spend on medical devices, which currently sits at USD 3. This is significantly lower compared to the global average of USD 47 and far behind developed nations like the USA and Germany.
Looking Ahead
The need for this bill lies in its potential to regulate e-pharmacies effectively. It also emphasizes the importance of having a deterrent against big Pharma companies and the need to recall medicines or devices if circumstantial issues are detected. The regulation aims to increase access and improve the rational use of essential medicines.