New Delhi: Shri JP Nadda, The Union Minister of Health and Family Welfare recently answered many grave questions raised in the Rajya Sabha pointedly asking the steps being taken by the government to investigate the unethical practices by companies in the medical devices industry that have come to light due to the global investigation-Implant Files;
During a parliamentary session, Shri Husain Dalwai raised a series of questions. He asked about the status of Medical Devices Regulation Bills. Further asking about the steps taken by the government in the light of the global investigation implant files he asked pointed questions related to certain medical devices and pharma products. These included
- The action taken against global pharma major for faulty hip implants;
- What action has been taken against that pharma major for suspected carcinogens in its
baby care products;
- How will the patients who received the faulty hip implants be compensated; and
- The redressal mechanism for a patient if a medical device/implant turns out faulty?
Giving a written response to these questions, the Minister informed that in order to have comprehensive regulatory provisions for import, manufacture, sale and distribution of medical devices, the Government has notified the Medical Device Rules, 2017 which has become effective from 01.01.2018 and there is no Medical Devices Regulation Bill under consideration of the Government.
Taking the issue of implant files the minister explained that comprehensive provisions already exist in medical Device Rules, 2017 to deal with regulatory issues in the medical devices sector.
He also apprised of various other measures
- “Materiovigilance Programme of India (MvPI)” is run by the Indian Pharmacopoeia Commission under the Ministry of Health & Family Welfare for strengthening the medical devices safety and performance through adverse events reporting.
- Moreover, The Uniform Code of Pharmaceuticals Marketing Practices (UCPMP) announced by the Department of Pharmaceuticals in December 2014 which has been in operation since 01.01.2015 for voluntary adoption by pharma industry provides that the manufacturers should not use any unethical practices for luring doctors to boost sales of their products.
The minister further stated about the action taken against global pharma major for faulty hip implants. In response to the reports of adverse events and recalls the Import license of M/s. DePuy Medical Private Limited (Now Johnson & Johnson) was cancelled under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945, he stated.
- Understanding the seriousness of the matter, the Government had constituted a committee to examine the issues relating to faulty ASR Hip Implants. The committee, after detailed examination of the issue, submitted its report to the Government, which accepted the recommendations with some modification. Based on the accepted recommendations, the Government constituted a Central Expert Committee under the Chairmanship of Dr R.K. Arya, Director, Sports Injury Centre inter-alia to determine the quantum of compensation.
- The Ministry of Health & Family Welfare has also requested all the States/UTs to form State Level Committees to examine the affected patients within their jurisdiction so that the process is less arduous for the patients.
- Furthermore, a formula for determining compensation for the affected patients has also been formulated and placed in the public domain. The affected patients are entitled to approach either the Central Expert Committee or State Level Committee as per their convenience.
- M/s Johnson & Johnson Pvt. Ltd. has been asked to comply with the recommendations of the Committee and to pay the compensation as per the formula approved by the Government in the interest of the patients.
However, the minister informed that M/s Johnson & Johnson Pvt. Ltd. has challenged the expert committee report on payment of compensation before the Hon’ble High Court of Delhi.
On the issue of Talcum powder, he stated that There were media reports that St. Louis jury in the USA in July 2018 had awarded nearly $4.7 billion in total damages to 22 women and their families after they claimed that asbestos present in Johnson and Johnson talcum powder had contributed to their ovarian cancer.
In light of the above, Central Drugs Standard Control Organisation, Ministry of Health & Family Welfare has asked its zonal offices to investigate the matter and draw samples under the provisions of the Drugs and Cosmetics Act, 1940 for verifying the compliance to the standards; he informed
The minister further informed that adverse events due to the use of medical devices/implants can be reported to the 10 dedicated Medical Device Adverse Event Monitoring Centres (MDMCs) functional under MvPI all over the country. MvPI has introduced various tools for adverse event reporting to develop India-specific data for making regulatory decisions by the CDSCO.