Draft Bill 2022 seeks to regulate e-pharmacies and medical devices

Centre also proposes to have an expert group on medical devices

The Union Health Ministry has released the draft ‘Drug, Medi­cal Devices, and Cosm­etics Bill-2022’ that seeks for the first time to regulate e-pharmacies.

The government also proposes to have a separate expert group on medical devices as well as set up medical device testing laboratories at the state and central levels. This would be similar to the network of drug testing laboratories in the country.

Moreover, the Bill also provides for penalties, including imprisonment, upon failing to pay compensation for death or injury during clinical trials, for both drugs and medical de­vices. The government has sought comments, objections, and suggestions on the draft Bill over the next 45 days.

E-pharmas look forward to comprehensive regulation of the sector

E-pharmacy companies feel strongly about the pending e-pharmacy rules as they say there is a need to have a comprehensive set of guidelines for the sector. “At present, the business is perfectly legal as it is covered under the IT Act and also the Drugs and Cosmetics Act. There is, however, a need for regulation in the sector to boost both investor and consumer confidence,” said the chief executive officer (CEO) of a leading online pharmacy.

The draft rules for e-pharmacies were released in 2019.

“As a group of e-pharmacy players, we have been patiently engaging with the regulators and the ministries for the last few years. We have participated in multiple stakeholder discussions.

While a draft notification on e-pharmacies was issued in 2019, the long policy and procedural issues continued to cause problems around ease of doing business in this space,” the CEO said.

He added, the draft Drug, Medical Devices, and Cosmetics Bill-2022 is a step in the right direction. A simple, clear regulatory pathway is a prerequisite for innovation to thrive in this important sector, the e-pharmacies feel.

A recent report by Systematix Institutional Equities said, “The online channel has garnered a 3 per cent share of the pharmacy market with a CAGR (compound annual growth rate) of 96 per cent in revenues to Rs 5,600 crore over FY15-21.”

The report further said that the e-pharmacy segment achieved a 47 per cent increase in revenues for FY21. This was spurred by Covid-related lockdowns and buyers’ reluctance to step out.

WHAT'S IN THE DRAFT

• E-pharmacies to be brought under regulation
• Separate expert group proposed for medical devices
• Medical devices not clubbed as drugs
• Compensation for clinical trials death and injury

Medical devices not to be treated as drugs

Unlike the previous Act of 1940, which regulated medical devices as a category of drugs, the draft Bill 2022 has a separate definition for medical devices.

These are brought under the ambit of diagnostic equipment, its software, implants and life-support, among others. The Bill goes a step further to make provisions for creation of a ‘medical devices technical advisory board’ or MDTAB on the lines of the existing drugs technical advisory board.

India’s medical devices industry has been seeking a separate statutory body for regulation of medical devices such as the Food Safety and Standards Association of India (FSSAI). FSSAI is an autonomous body under the ministry of health and family welfare.

“Food is different from drugs. And thus, the FSSAI was created to monitor it. Similarly, the NITI Aayog is of the opinion that a separate body needs to be created for medical devices too,” an industry source had told Business Standard earlier.

The local industry is disappointed in not having a separate Act for medical devices. “We are disappointed that our aspirations for a separate Act for medical devices have not been addressed. However, on the positive side, we are pleased to find that there is a proposal to have a separate board for medical devices. This was a long-standing demand,” said Rajiv Nath of the Association of Indian Medical Devices Industry (AiMeD). The industry feels that the Drugs Technical Advisory Board (DTAB) is not equipped to understand the engineering aspects of medical devices.

The draft Bill 2022 says that the DTAB will not only include medical professionals, but also experts on devices. 

Regulating clinical trials of drugs and devices

For the first time, regulations for conducting clinical trials for new drugs and medical devices have been brought under the draft Bill.

This is a critical step. Currently, clinical trials for new drugs and medical devices are regulated under the New Drugs and Clinical Trials Rules, 2019. The draft Bill provides for penalties if someone suffers due to use of spurious drugs.

AYUSH in focus

AYUSH drugs are in focus as the draft Bill has a separate chapter on this segment. It also seeks to regulate Sowa Rigpa and homeopathy.