- Outline of the new framework
- Need for the new framework
- What if current proposal is adopted?
- IT’s Input
Proposed Medical Device Regulatory Framework in India
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- All imported and locally-made medical devices will have to meet certain standards of quality and efficacy to enter the Indian market. The government has begun framing the rules and a draft notification to this effect is likely to be put out soon.
Outline of the new framework
- All import, manufacture and sale of medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO).
- The CDSCO will be the nodal authority to investigate quality, safety-related issues and complaints and can suspend the registration based on the outcome of its investigation.
- To increase safety of end users of such devices.
Need for the new framework
- Currently, only 23 categories of medical devices are regulated in India under the Drugs and Cosmetics (D&C) Act.
- The government does not have an exact figure for how many non-notified medical devices are available in India.
- There have also been complaints of refurbished imported equipment imported illegally in India.
- Indian government overhauled the medical device regulatory process in 2017 with the publication of the Medical Device Rules using powers under the Drugs and Cosmetics Act. At that time, only a few medical devices were notified as drugs.
- In a recent notification, the government announced to treat all medical devices, be it an implant or a MRI machine as drugs under the Drugs and Cosmetics Act. This means that all medical devices would be placed within the framework of the Medical Device Rules, 2017.
Criticism of Medical Device Rules 2017
The Health ministry cannot create new penalties as only Parliament can enact a law that creates new offences and penalties for wrongdoing. As a result, the Medical Device Rules 2017 contain no penal provisions.
What if current proposal is adopted?
- If the current proposal is adopted, companies that make defective products will recall them from foreign markets while continue to sell the same product in India.
- Even in the presence of penalty provision for sale of sub-standard drugs, as there is no political will, most manufacturers who make poor quality drugs will not be punished.
- Under the present proposal, no prosecutions will take place for international companies because there will be no basis to prosecute intentional wrongdoing in the law.
- Medical devices are far more difficult to standardize when compared to drugs. The Health ministry can prohibit the manufacture of certain medical devices under Section 26A or cancel a license. However, under the proposed framework, there is no penalties to punish for the harm already inflicted on patients due to negligence wrongdoing by the manufacturer.
- Since the manufacturer sold Medical devices to doctors and hospitals and not patients directly, it did not have a list of patients who had these devices implanted in their body. Hence government cannot find list of all the patients with faulty implants.
- Therefore, there is need to create a confidential patient register, maintained by the government, to record all details of implants. This register could be used to notify patients in the case of malfunctioning devices.
- Medical devices are not drugs, and it would be a grave mistake to apply the same regulatory framework to regulate these complex devices.
- The need of the hour is for new ideas to regulate this industry in the Indian context where the courts lack the capacity to tackle such complex issues.
Medical Device Rules, 2017
- Medical devices under the Rules “Medical Devices Rules, 2017” are classified as per Global Harmonization Task Force (GHTF) based on associated risks: Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk).
Key Features of Medical Device Rules, 2017
- No requirement of periodic renewal of licenses/registrations. Accordingly, manufacturing and import licenses will remain valid till these are suspended or cancelled or surrendered.
- Entire process starting from submission of application to grant of permission/licence is online.
- The registration document review, submission & tracking have become much simpler& transparent with the SUGAM system.