From November 1, next year, import, manufacture and sale of the ultrasound machines will be allowed only under the legal ambit of the Drugs and Cosmetics Act, 1940.
The Union Health Ministry has issued a notification in this regard on Thursday according to which the device intended for external or internal use in human beings has been categorised as drug with effect from November 1, 2020.
The step aims to regulate the import, manufacture and sale of the devices to stem the drastic decline in India’s sex ratio, as per the Ministry. The move followed recommendation from the Drug Technical Advisory Board (DTAB), the Government’s chief advisory body on drugs.
According to an official from the Ministry, from November next year, the Central Drugs Standard Control Organization (CDSCO), the national regulatory body for Indian pharmaceuticals and medical devices, will become the approving authority for import, manufacture and sale of ultrasound machines. The companies will also have to apply for permission from the Drug Controller General of India, who is responsible for approval of licences, before the scanners are sold in India.
The health ministry feels that the move is crucial to save the girl child as it will check misuse of such techniques for sex selection after conception. Imported machines have flooded the market, in the absence of any regulatory check, they cannot be tracked.
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, the Ministry was not finding the existing rules sufficient to deter the medical professionals and the user, to avoid ultrasound to determine the sex of the foetus. Mainly because of its easy availability on online as well.
Under the Medical Device Rules (MDR) and the D&C Act the government will regulate additionally the quality import and manufacturing of the equipment, he said.
While welcoming the move, Rajiv Nath, Forum Coordinator of the AiMeD, an umbrella association of Indian Manufacturers of Medical Devices covering all types of medical devices including consumables, disposables, however was not happy at the Government’s ‘pick and choose policy.”
He said that the manufacturers have been confused with informally and arbitrary choosing of products and notifying them as drugs. “At AiMeD we welcome regulations but not of these kinds . Our members seek a predictable and comprehensive regulatory framework that allows for adequate transition and is predictable. Only then will investments speed up as manufacturers get discouraged to be regulated as Drugs , item by item and not as a category,” said Rajiv Nath.
The move is also not in keeping with the Health Ministry- DTAB Roadmap that aimed to regulate all devices in a phased manner and assured an adequate transition period of nearly four years for high Risk and near High Risk Devices. “The one year transition period is not as per the assurance given of four years,” he added.