Expert committee to formulate new laws for medicines, cosmetics and medical devices

In a bid to replace the existing Drugs and Cosmetics Act 1940, the government has set up an expert committee to frame new laws for medicines, cosmetics and medical devices. The Ministry of Health and Family Welfare has formed an eight-member committee, which is headed by the drug regulator.

The expert committee, as per the health ministry, shall undertake pre-legislative consultations and examine the present Act, previously framed drugs and cosmetics bills and submit a draft document for a de-novo drugs, cosmetics and medical devices bill by November 30, 2021.

The Drugs and Cosmetics (D&C) Act, 1940, regulates the import, manufacture, distribution and sale of drugs and cosmetics. It should be noted that both drugs and medical devices are now regulated by the Central Drugs Standard Control Organization (CDSCO) under the health ministry; and at present there is no difference between the regulatory treatment of drugs and medical devices.

Experts had said that with the incorporation of all medical devices into the definition of drugs, a lack of comprehensive system of checks could prove disastrous. Concerns had been raised that with companies looking domestically for manufacturing, there is a need to ensure effective regulation of the sector.

The February 2020 notification, namely a revised definition of medical devices and Medical Device (Amendment) Rules 2020 stated that manufacturers and importers of medical devices can increase the MRP of a drug up to 10% of the MRP during the preceding 12 months which would be monitored by the government to avoid overcharging. It highlighted that increased the MRP more than 10% would be considered as overcharging and manufacturers and importers will have to deposit the amount overcharged with interest and penalty.

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Growing demand for medical devices and domestic manufacturing

Over the past year since the advent of COVID-19 pandemic, medical devices companies skyrocketed the price of essential devices such as ventilators and the second wave of infections accelerated the demand even further, leaving a drastic impact on the supply chain. The Ministry of Health and Family Welfare (MoHFW) in a report in December 2020 stated that prior to COVID-19, the average cost of each ventilator in March 2020 was Rs 15 lakh. However, due to the Indian ventilator industry taking up the production, the cost is about Rs 2-10 lakhs.

And this also paved the way and growing demand for domestic manufacturing. According to ManagingIP, these devices have become common in small medical institutions and more people are opting for home healthcare, resulting in an increase in demand for medical devices that can be used at home.