New Delhi: Imaging and endoscopic equipment like ultrasound machines, CT scanners, magnetic resonance imaging (MRI) and X-Ray machines are to be brought under the purview of the Drugs and Cosmetics Act so that the government can regulate their import, manufacture and sale.
The Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, will become the approving authority for the import, manufacture and sale of these devices. Companies that deal in these will also have to apply for permission from the Drug Controller General of India, which is responsible for approval of licences, before they can sell the devices in India.
The Drug Technical Advisory Board (DTAB), the government’s chief advisory body on drugs in its meeting on 12 February decided to include ultrasound equipment under the purview of the Drugs and Cosmetics Act, 1940.
Stringent regulation of ultrasound machines is thought to be critical in addressing the drastic imbalance in India’s sex ratio and helping save the girl child.
“The DTAB deliberated the matter and agreed to include ultrasound equipment and similar imaging equipments under the purview of section 3 9b) (iv) of the Drug and Cosmetics Act, 1940," says the minutes of the DTAB meeting which Mint has reviewed.
“The regulation of ultrasound machines will help prevent the misuse of sex selection techniques used unabated after conception. In the absence of any regulatory check, imported machines have flooded the market and cannot be tracked," said an official requesting anonymity. The Pre-Conception and Pre-Natal Diagnostic Techniques (PC-PNDT) Act, 1994 currently regulates the sale of ultrasound machines only to entities registered under the law. “However, tighter oversight of these equipments is aimed at addressing the continual decline in the sex ratio with each national census," added another person.
India’s sex ratio has declined from 945 females for every 1,000 males in the zero to six years age range in 1991 to 927 females in 2001, according to census data. It declined further to 914 females in 2011.
Supporting the government’s move, Nalinikanth Gollagunta, president and CEO, GE Healthcare, South Asia said, “It is a welcome move... It will lead to a clear distinction between the compliant and non-compliant players. There will be a clearer record and understanding of ultrasound products coming into the market and this in turn can help in easier implementation of the PNDT Act. On a broader note, the medical device industry has reached a certain level of scale and complexity which deserves its own dedicated regulatory framework like a Medical Device Act."
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AIMED) said the government’s plan “is a good move to address concerns of patient safety and calibration to assure quality of these medical equipment specifically as pre-owned medical electronics equipment is entering the country via imports without any safeguards so far."