January 2014 1254

PC PNDT Act – A Maze for Ultrasound Suppliers

Himanshu Bhatt, Director, KS Biomed

Implementation of Pre-Conception and Pre-Natal Diagnostic Techniques (PC PNDT) ACT 1994 was a much needed measure, however has lacunae on comprehensive guidelines for industry In country like India where there is visible disparity in treatment or perception to individuals based on their gender, implementation of Pre-Conception and Pre-Natal Diagnostic Techniques (PC PNDT) ACT 1994 was a much needed measure taken by Indian Government that has taken to control gender imbalance. The outcome of this legal action is very encouraging and in many states the gender imbalance is improving at a significantly fast pace. In addition to doctors and clinicians medical equipment industry also are co-operating extensively in implementation of this Act for over all benefit of all citizens of India.

Two Sides of the Coin
Today, there are certain practical difficulties that the ultrasound industry is facing while following PC PNDT Act. All legal guidelines implemented by legal Act are compulsory and we as industry are bound to follow same while performing our business practices. From the time of its implementation PC PNDT Act is focused on stopping pre-natal sex determination and was applicable to all who were involved in this mainly, practitioners and patients. With additional amendments later on, this Act also implemented certain rules for ultrasound suppliers like manufacturer, vendor, dealer or distributor and also technical service provider. Individual registration of ultrasound supplier was made compulsory in each district of each state across the country. An arduous task for the industry, yet this has been followed in all spirit and cause of the Act. A new challenge that has come in front of us is the practical difficulty of how to manage a legal demonstration of an ultrasound to a doctor. There is no clear guideline for demonstration process in the PC PNDT Act.

Absence of Demo Guidelines
Ultrasound is an application base technology and there are continuously new technology features and advances in newer generation equipments and products. Live demonstration is a must for industry as well as for clinicians to watch, understand and monitor these technologies as there is a direct financial implication involved for both the supplier as well as the buyer. Basic aspect of image quality, over all resolution, measurement packages among others had to be demonstrated for a complete evaluation of system. Thus in absences of clear guideline in PC PNDT Act, ultrasound demonstration have become difficult and risky unless and until appropriate approvals are not taken for movement of the equipment. Also the interpretation of PNDT ACT is still not uniform to all the authorized offices and leaves huge risk of seizing complete equipment while demonstration process and one has to face legal consequences in spite of following over all rules as per PC PNDT Act. There are plenty of examples where one district office approves demonstration but in the same state another district office denies permission.
Looking to these practical issues of conducting on-site live demonstration for each prospective buyer, we strongly feel that current time demands a clear co-operation from clinicians to take live demonstration either at approved site where same equipment is already installed or at manufacturers approved site where pregnant cases should be avoided while demonstration scans. An intervention from the government to release focused and transparent policy/guidelines in PC PNDT Act for ultrasound suppliers for supply and live demonstration of ultrasound systems would be a boon for the industry.

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