12-Feb-2019: Guidelines regarding re-use of Medical Devices
The Government of India has enacted the Clinical Establishments (Registration and Regulation) Act, 2010 and notified Clinical Establishments (Central Government) Rules, 2012 for registration of Clinical Establishments with a view to prescribing the Minimum Standards of facilities and services provided by them.
Under the said Act, the National Council for clinical establishments has approved Minimum Standards for different levels of Hospitals. These minimum standards inter-alia provide that the hospitals should have adequate drugs, medical devices and consumables commensurate to the scope of services and number of beds.
These standards further provide that the quality of drugs, medical devices and consumables shall be ensured. The Hospitals are also required to follow standard precautions like practicing hand hygiene, use of personal infection equipment etc. and infection control practices including compliance to Bio-Medical Waste Management Rules to reduce high risk of healthcare associated infection.
Currently, the Act has been adopted by 11 States namely, Sikkim, Mizoram, Arunachal Pradesh, Himachal Pradesh, U.P, Bihar, Jharkhand, Rajasthan, Uttarakhand, Assam and Haryana and all Union Territories except Delhi. The implementation and enforcement of the said Act fall within the ambit of the States/Union territories.
As per Constitutional provisions, ‘Health’ is a State subject and such issues would generally be addressed to the State/Union Territory concerned for taking appropriate action as per the provisions of Act and Rules applicable in the concerned State/UT. Data regarding the complaints received by States and action taken by the State to reimburse the affected patients is not maintained centrally.
Further, Central Government has published Medical Devices Rules 2017 effective from 01.01.2018. As per the said rules, Medical Device intended to be used for single use should be labeled appropriately.
5-Feb-2019: Kerala Sets Up Drug Price Monitor
Kerala has become the first State to set up a Price Monitoring and Research Unit (PMRU) to track violation of prices of essential drugs and medical devices under the Drugs Price Control Order (DPCO). The move comes more than five years after the National Pharmaceutical Pricing Authority (NPPA) proposed such a system for the States and the Union Territories.
A society had been registered to get Central assistance for the functioning of the unit. The new office would start functioning as soon as infrastructure is set up. There is no price control review mechanism now.
The State Health Secretary would be the Chairman of the society and the Drugs Controller would be its member secretary. Its members include a State government representative, representatives of private pharmaceutical companies, and those from consumer rights protection fora. The society would also have an executive committee headed by the Drugs Controller.
The new watchdog will offer technical help to the State Drug Controllers and the NPPA to monitor notified prices of medicines, detect violation of the provisions of the DPCO, look at price compliance, collect test samples of medicines, and collect and compile market-based data of scheduled as well as non-scheduled formulations.
Pharma companies have been accused of overcharging prices of drugs in the scheduled category fixed by the DPCO and those outside its ambit too.
The suggestion to set up PMRUs was made against the backdrop of the lack of a field-level link between the NPPA and the State Drugs Controllers and State Drug Inspectors to monitor drug prices.
States and Union Territories have been classified into three categories for staff recruitment and infrastructure. Kerala falls in the second category, having a population of less than 3%, but more than 1% of the total population of the country. The State will have a project coordinator, two field investigators, and two data entry operators. The unit is expected to help the State Drugs Control wing, which is hit by severe staff shortage, and regulate drug prices more effectively.
The NPPA had fixed the prices of around 1,000 drugs and the unit would track if buyers were being overcharged. It would also check if pharma companies were hiking the prices of non-scheduled drugs by more than 10% a year. There is also a plan to collect data on the prices of surgical devices and stents in the market.
10-Dec-2018: Medical devices under the purview of the Drugs and Cosmetics Act
Medical devices such as blood pressure monitors, nebulizers, digital thermometers and glucometers may cost less as the government has decided to bring them under the purview of the Drugs and Cosmetics Act, in a move to ensure performance and enable price and control checks. Once the proposal gets the green signal, all the companies engaged in manufacture and import of these devices will need to get approval or license from the Drug Controller General of India (DCGI) from January 2020 onwards.
The Minister of Healthcare and Family Welfare has notified that “…specified devices intended for use in humans for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, to be included in the definition of drug under the Drugs and Cosmetics Act, 1940; effective from January 1,”.
India’s highest drug advisory body – The Drug Technical Advisory Body (DTAB) – had cleared the proposal to include blood pressure monitoring devices, nebulizers, digital thermometers and glucometers under the purview of the Drug law. Therefore, all such devices will have to be registered under the quality parameters prescribed under Medical Devices Rules, 2017 and other standards set by the Bureau of Indian Standard (BIS) certification.
As of now, just 23 medical devices are monitored for quality by DCGI. With the inclusion of four new devices, there will be 27 medical devices under the definition of drugs under the Act. Other medical equipment are currently sold without any clinical trials or quality checks.
The ministry has also proposed to expand the list of devices in eight new categories, including MRI equipment, CT scan equipment, defibrillators, dialysis machines, PET equipment, X-ray machines and bone marrow cell separator, under the purview of the drug law. The proposal is being deliberated.