From UPSC perspective, the following things are important :
Prelims level : Nothing much
Mains level : Medical devices regulations in India
The Ministry of Health and Family Welfare is going to put in place a regulatory framework for medical devices that will favor the lobbyists for the medical device industry. The medical industry has already proven itself to be brazenly irresponsible towards patients in India as we are seeing in the ongoing hip-implant scandal.
Steps towards regulation
- Regulation, not law – Rather than moving a new law to regulate the medical device industry, the ministry is creating a regulatory framework out of notifications and rules, using powers delegated under the Drugs and Cosmetics Act, 1940.
- The ministry notified the Medical Device Rules, 2017 using powers under the Drugs and Cosmetics Act. At that time, only a few medical devices were notified as “drugs”.
- In the latest notification, the government announced its intention to treat all medical devices as “drugs” under the Drugs and Cosmetics Act. All medical devices would be placed within the framework of the Medical Device Rules, 2017.
- Poor regulation – retrofitting medical devices into the Drugs and Cosmetics Act will lead to a toothless regulatory framework for devices, similar to what exists for drugs today.
Problems with the move
- Bypassing parliament – The ministry cannot create new offenses or penalties through its rule-making authority. Only Parliament can enact a law that creates new offenses and penalties for wrongdoing. The Medical Device Rules 2017 contain no penal provisions.
- No legally binding provisions – Although the Drugs and Cosmetics Act contains a penal provision for the manufacture of substandard drugs, it cannot be used to penalise manufacturers of sub-standard medical devices. Legally binding standards recognised in the Second Schedule to the Drugs and Cosmetics Act covers only pharmacopeias for drugs.
- If no standards for medical devices are recognised in the Second Schedule, there can never be a prosecution of a manufacturer of sub-standard medical devices.
- Foreign markets – Companies that make defective products will recall them from foreign markets and sell the same product in India, and comply with the law.
- Even though the sale of substandard drugs can be prosecuted under the current law, most manufacturers who make poor quality drugs go scot-free.
- No prosecutions will take place because there will be no basis to prosecute intentional wrongdoing in the law.
- Standards of medical devices – Medical devices will be far more difficult to standardise when compared to drugs.
- No tools – There are no tools available to Indian regulators under the proposed framework to hold makers of sub-standard medical device manufacturers to account. At most, the ministry can prohibit the manufacture and sale of certain medical devices under Section 26A or cancel a license to prevent future harm.
- Past errors – There are no penalties or prosecution to punish for the harm already inflicted on patients due to negligence or worse, intentional wrongdoing by the manufacturer.
- Registry of patients – One of the main challenges faced by the government in securing justice for faulty hip-implants was to secure a list of patients who had received the implant through surgery.
- Neither the doctors nor the hospitals have an incentive to share the list of patients or even inform the patients because it would mean opening themselves up to legal liability for surgically implanting faulty devices in the patient’s body.
- The proposed regulatory framework will do little to hold the powerful medical devices industry accountable in cases of intentional wrongdoing.
- Medical devices are not drugs, and it would be a grave mistake to apply the same regulatory framework to regulate these complex devices.
- Create a confidential patient register that should be maintained by the government to record all details of implants.
- This register could be used to notify patients in the case of malfunctioning devices.
- The government must rethink this toothless framework and instead enact a new law through Parliament.
- There is a need for new ideas to regulate this industry in the Indian context where the courts lack the capacity to tackle such complex issues.