A recent proposal by the Ministry of Health and Family Welfare aims to bring under the purview of the Drugs and Cosmetics Act, 1940, all instruments or devices implemented for medical application. If this draft notification is enacted, all such entities will be defined as “drugs.” The category extends to include any medical instrument, apparatus, appliance, implant, material or other article, which can be used on its own or in combination with others, for human beings or animals as well. This regulation will require manufacturers and importers of most of these devices to voluntarily register with the Central Drugs Standard Control Organisation (CDSCO) within a span of 1.5 years.
The Reasons Underpinning the Draft Proposal
One key reason motivating this proposed regulation is the danger posed by defective implants, which could lead to severe pain and even death. A notable example in this context surfaces from the Johnson and Johnson’s faulty hip implants case in 2018.
In this incident, the Johnson and Johnson’s hip implant named Pinnacle was discovered to be leaking cobalt-chromium ions into the body. This led to grave health complications including blood metal poisoning, debilitating pain, and damage to various body organs. The company compensated US patients who had received the defective implants, but it has contested the government orders in India to compensate the 4,700 patients who underwent hip replacement surgeries with the defective implants.
Implications of the Proposed Regulation
If this regulation is enacted, the CDSCO, as the country’s drug regulator, will enforce standards to ensure the safety and effectiveness of these products, while the National Pharmaceutical Pricing Authority (NPPA) will oversee the prices. Both entities have a mandate to apply their respective provisions on all medical devices and penalize violations under the Act.
The NPPA is tasked with monitoring drug prices to ensure that increases do not exceed 10% each year.
Key Challenges and The Way Ahead
| Organisation | Function |
|---|---|
| Central Drugs Standard Control Organisation (CDSCO) | Regulatory control over the import of drugs, approval of new drugs and clinical trials, and approval of certain licenses |
| National Pharmaceuticals Pricing Authority (NPPA) | Revision of prices of controlled bulk drugs and formulations, enforcement of prices and availability of medicines in the country |
However, despite these regulations, the application of medical regulations is marked by considerable delays. An example of this was witnessed when the Food and Drug Administration of Maharashtra ordered a halt to the import of Johnson and Johnson’s hip implants, soon after the company withdrew the product from the global market. Yet, it took an additional year for the CDSCO to ban its import.
Given the increasing safety disasters involving devices, mere expansion of regulation scope is insufficient. Consequently, there is a pressing need to establish a new medical devices act. Therefore, additional measures for improved safety and healthcare standards must be incorporated while considering this proposed regulation.
About CDSCO and NPPA
The CDSCO is the central drug authority responsible for performing functions delegated to the central government under the Drugs and Cosmetics Act. The primary tasks include regulatory control over the import of drugs, approval of new drugs and clinical trials, and approval of particular licences as a central licence approving authority.
Conversely, the NPPA is an entity under the Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, instituted in 1997 to revise the prices of controlled bulk drugs and formulations and enforce the availability and prices of medicines in the country regulated under the DPCO, 1995. Currently, prices are fixed or revised under the DPCO, 2013. Additionally, the NPPA monitors the prices of decontrolled drugs to maintain them at reasonable levels.
Last Modified: February 6, 2024