1Regulatory Affairs & Quality Assurance- Head, Bard India Healthcare Private Limited, Mumbai, Maharashtra, India
2Regulatory Affairs and Quality Assurance- Assistant Manager, Bard India Healthcare Private Limited, Mumbai, Maharashtra, India
3Regulatory Affairs- Executive, Bard India Healthcare Private Limited, Mumbai, Maharashtra, India
4Pharmacoinformatics, National Institute of Pharmaceutical Education & Research (NIPER), S.A.S. Nagar, Mohali, Punjab, India
5Institute of Clinical Research (India)-ICRI, New Delhi, India
6M.S. (Pharm) Biotechnology, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, Patna, Bihar, India
*Corresponding author email id: manish.ragtah14@gmail.com, manish.ragtah@crbard.com
Online published on 10 December, 2015.
As per the Pre-Natal Diagnostic Technique (PNDT) Act and Rules 1994, ultrasound devices and machines cannot be freely sold. Section 3 of PNDT Act prohibits the sale of ultrasound machine to persons, laboratories, clinics, etc, not registered under the PNDT authority. The intent of this Act is to prohibit the diagnostic techniques for determination of the sex of the foetus leading to female feticide, and hence this Act covers all the ultrasound machines irrespective of its intended use. PNDT Act is a central Act but its implementation has varying interpretations in different states of India.
A set of questions was chosen to be asked from the officials of PNDT authorities of different states related to demonstration and sale of ultrasound machines.
PNDT Act is considered as a very sensitive Act by all PNDT officials and has a requirement of hospital registration under PNDT authority before the demonstration and sale of ultrasound machines. Maharashtra and Gujarat has a specific requirement of importer and dealer registration under PNDT authority before the demonstration and sale.
On the Basis all this, there is a need of clear guidelines to healthcare professionals and healthcare providers that will be uniformly applicable to all states across India.
PNDTAct, Ultrasoundmachine, Regulation, Pre-natal, Sex determination
