New Delhi: To control the import, manufacturing, and sale of the Imaging and endoscopic equipment like ultrasound machines, CT scanners, magnetic resonance imaging (MRI) and maybe even X-Ray machines government is going to bring them under the purview of the Drugs and Cosmetics Act.
In its meeting on 12 February, the Drug Technical Advisory Board (DTAB) has decided to include ultrasound equipment under the purview of the Drugs and Cosmetics Act, 1940 in order to save the girl child as the stern rule of ultrasound machines is thought to be critical in addressing the drastic imbalance in India’s sex ratio.
According to the minutes of the DTAB meeting which has been reviewed by Mint, “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,”
Prior to selling their devices in India, companies will have to apply for permission from the Drug Controller General of India who is responsible for the approval of licenses as the Central Drugs Standard Control Organization (CDSCO), will become the approving authority for the import, manufacture, and sale of these devices.
Currently, The Pre-Conception and Pre-Natal Diagnostic Techniques (PC-PNDT) Act, 1994 regulates the sale of ultrasound machines only to entities registered under the law.
Welcoming the government step, 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.”
Speaking with Mint, 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.”