Introduction – PC & PNDT Approval for Ultrasound Import into India

This article deals with the PC & PNDT Approval for Ultrasound Import into India: for the import of Ultrasound into India. As per the Pre Conception and Pre Natal Diagnostic Techniques Act of 1994, Sex Determination is illegal in India. The Government is regulating the Import, Manufacture and Sale of Ultrasound Machines to prevent the misuse of sex selection techniques after conception. Earlier to Import ultrasound or any other imaging equipment as there was no License required, and therefore it was difficult to track the quality of these products.  Companies are still opposing the proposed regulation stating the usage of ultrasound machines is not only for sex determination tests but also used for many other diagnostic purposes. However, the Government is strongly regulating the import of these machines.

Pre Conception and Pre natal Diagnostic Techniques Act (PC-PNDT )

The (PC-PNDT) Pre Conception and Pre natal Diagnostic Techniques Act 1994, the pre consumption or pre-natal sex determination is illegal in India. The (PC-PNDT) Act, 1994,  meeting held recently, in which the X-Ray machines, CT scans, MRI machines and endoscopes are the other equipment were also regulated by the decision of the government. The main aim of these rules is to regulate the clinical Investigation, manufacture, Import, sale and distribution of the medical devices in the country.  Companies must apply for a license and get permission, before the scanners are sold in India. Health ministry has taken up the issue with the DCGI to prevent the misuse of such techniques for sex selection after conception. Regulation of prenatal diagnostic techniques for the purposes of detecting genetic abnormalities, metabolic disorders, any kind of chromosomal abnormalities, congenital malformations, sex-linked disorders and for the prevention of their misuse for sex determination leading to female foeticide is the main function of this Act.

Conclusion:-

The (PC-PNDT) Act, 1994 thus regulates the sale of ultrasound machines only to those who have registered under the law. The health ministry has further recommended more tight and strict rules of the equipment, following the continual decline in the sex ratio with each national census. The Drugs and Cosmetics Act should plug the loopholes in the PC-PNDT Act, on how it will be used for medical equipment like ultrasound. Central Govt has notified Ultrasound equipment intended for external or internal use in human beings as drugs, as per D&C Act of 1940, with effect from November 1, 2020 as per the SO 3721 (E). This Act helps in the prohibition of sex selection, before or after conception, to prevent of their misuse for sex determination leading to female foeticide.

How can Morulaa Help

Morulaa HealthTech as a successful regulatory and Import Consultants have delivered high levels of professionalism towards our clients. Contact us to know more on the import of Medical Devices into India. 


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