Med devices to be termed as ‘drugs’ from Apr 1
   Date :17-Feb-2020
Med devices to be termed
 
 
By Rajendra Diwe :
 
A Gazette Notification of Ministry of Health, Government of India regulating medical devices as Drug received mixed responses from Pharma field
 
 
“All medical devices will now be regulated as ‘drug’ under the Drugs and Cosmetic Act 1940 with effect from April 1, 2020,” says Union Health Ministry in a gazette notification issued on February 11. The ministry after consultation with Drugs Technical Advisory Board (DTAB) has further notified to amend the Medical Devices Rules, 2017 and has specified that these rules may be called the Medical Devices (Amendment) Rules, 2020 and shall come into force on April 1, 2020. Pharmacists in city, FDA officials, members of consumer bodies, traders and members of social groups in city sharply reacted over the notification.
 
Amrut Nikhade, former Joint Commissioner, Food and Drugs Administration (FDA) Mumbai welcomed the decision and said, “It was necessary from long time to regulate the medical devices as drug.” Stating that there is nothing new about this notification, Nikhade added, “The medical devices are actually defined in Drugs and Cosmetic Act as ‘drug’. Previously very few devices were included in the definition, but from time to time according to demand, Government is expanding the list of medical devices.” Till date, only 23 medical devices have been classified as drugs.
 
Of these, only a few including cardiac stents, drug eluting cardiac stents, condoms, intrauterine devices, have been brought under price control. Now, the present notification lists 37 devices and equipment whose quality and manufacturing standards will be regulated, which includes a host of devices and equipment like nebulisers, blood pressure monitoring device, glucometer, digital thermometer, all implantable medical devices equipment, CT scan equipment, MRI Equipment, defibrillators. “Medical devices and medical technology equipment used for ‘diagnosis, monitoring, treatment, investigations and for supporting or sustaining life are categorised as ‘drugs’, under the Drug and Cosmetics Act, 1940, from April this year. Now many more medical devices will come under the purview of D&C Act,” Nikhade said. Prince Uppal, Director of Uppal Surgical in city welcomed the decision of Government to treat medical devices as Drug with some hesitations.
 
He pointed out, “Price regulation of medical devices as ‘Drug’ is very good, but what about quality, standards and monitoring the import of medical devices? The term medical devices has been used in larger sense. There are number of devices right from syringe, scalp vein set, etc, used in rural areas. Many small scale industries are manufacturing and supplying these devices. In addition to price regulation, Government should monitor the manufacturing, quality and standards of these devices supplied in market. Most of these devices are being imported from China.
 
Do the Government has a capable work force to monitor the quality and standards of medical devices? As per the scientific standard each medical device used in health care requires calibration or standardisation before they are used. What provisions Government has made in this regards?” Nitish Kulkarni, a pharmacist in city reacted, “The present notification says all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings.... and which may assist in specific purposes of diagnosis, prevention, monitoring, treatment or alleviation of any disease, will be classified as a drug. Government has already regularised the prices of stents, catheters and other materials. Unfortunately, patients are not getting the benefits of this price control.
 
Even after the price control, common patients are paying exorbitant amounts. Patients undergoing surgeries like cataract and many corporate hospitals in city are charging huge amounts on the basis of ‘lens’ patients had selected. Who really knows the quality and standards of the medical devices or implants?” Nilesh Kothari of Pharmacists Society of India said, “At present the Gazette Notification sounds good. As a Pharmacist, I have to welcome the decision.
 
The medical device industry is about 15 billion dollars in the country. About 70 to 80 per cent medical devices including imaging equipment (CT and MRI scanners), cardiac stents, orthopaedic implants, syringes, surgical gloves, glucometers, and critical care equipment, etc are imported from other countries. After April 1, 2020, when the implementation starts, the pharmacists in the country could be able to understand the lacunae in the decision.” Sonali Padole of Ladies Wing of Nagpur District Chemists and Druggists Association (NDCDA) also supported the Government’s decision and opined that the benefits of this decisions should be passed to common patients who are paying high prices for the small devices.
 
The consumer groups though termed the move as positive expressed doubts about Central Drugs Standard Control Organisation’s (CDSCO’s) current ability to regulate devices under the wider scope. Malini Aisola, co-convener, All India Drug Action Network (AIDAN) said, “We are particularly wary of the CDSCO’s competence, expertise and most importantly its commitment towards patient safety, given its dismal track record. We urgently need comprehensive reforms to strengthen the regulatory mechanism in relation to patients’ safety. These may include guidelines for the approval of devices including clinical investigation requirements, oversight of marketing and promotion, putting in place a robust and functioning system of adverse event reporting accessible to the public, rules for voluntary and statutory recalls, and patient compensation scheme.”