GOVERNMENT OF INDIA
MINISTRY OF HEALTH AND FAMILY WELFARE
DEPARTMENT OF HEALTH AND FAMILY WELFARE
UNSTARRED QUESTION NO. 1681
TO BE ANSWERED ON 2ND JANUARY 2018
REFORMS IN REGULATORY FRAMEWORK FOR CLINICAL ESTABLISHMENTS
1681. SHRI RAJEEV CHANDRASEKHAR:
Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:
(a) The steps taken by Government to reform the regulation of clinical establishments, professional and technical education, food safety, medical technologies, medical products and clinical trials given that the National Health Policy 2017 advocates a larger role for the private sector; and
(b) The measures taken by Government for better protection of consumers from private medical establishments given the recent allegations of overcharging, negligence and malfeasance?
THE MINISTER OF STATE IN THE MINISTRY OF HELATH AND FAMILY WELFARE
(SMT. ANUPRIYA PATEL)
(a) The steps taken by Government to reform the regulation of clinical establishments, professional and technical education, food safety, medical technologies, medical products and clinical trials is at Annexure.
(b) Health is State subject. Regulation of clinical establishments including private clinical establishments and to take appropriate measures for better protection of consumers from private medical establishments fall within the purview of State/UT Governments.
The Government of India has however, enacted Clinical Establishments (Registration and Regulation) Act, 2010 for registration and regulation of all clinical establishments in the country. In accordance of the Clinical Establishments (Central Government) Rules, 2012 notified under the said Act, the clinical establishments are required too follow Standard Treatment Guidelines as may be issued by Central / State Governments, display their rates at a conspicuous place and charge the rates for each type of procedures and services within the range of rates determined from time to time in consultation with the State Governments. The National Council for Clinical Establishments has approved a standard list of medical procedures and a standard template for costing of medical procedures which has been shared with the States/UTs where the Act is applicable for talking appropriate action by them. The implementation and enforcement of the said Act falls within the remit of the States/Union Territories.
The Clinical Establishments Act, 2010 provides sufficient scope for the States and Union Territories for effectively redressing public grievances and curb unethical medical practices. Further, the MCI and State Medical Councils are empowered to take action against a doctor for violation of the provisions of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002. The complaints related to overcharging, deficiency in medical care, etc. can also filed in District/State/National Consumer Disputes Redressal Forums under the Consumer Protection Act.
Regulation of Clinical Establishment: Health is a State subject. The Government of India has, however, enacted Clinical Establishments (Registration and Regulation) Act, 2010 for registration and regulation of all clinical establishment in the country (both Government and Private) with a view to prescribing the minimum standards of facilities and service provided by them.
Currently, the Act is applicable in 10 States namely Sikkim, Mizoram, Arunachal Pradesh, Himachal Pradesh, Uttar Pradesh, Bihar, Jharkhand, Rajasthan, Uttarakhand and Assam and all Union Territories except Delhi. Other States may adopt the Act under clause (1) of Articles 252 of the Constitution.
Clinical Trials and Medical Technology: The Central Drugs Standard Control Organization (CDSCO), Government of India controls the conduct the clinical trials and registration of medicines in India and has recently revised the regulations. The regulations ensure the rights, safety and well-being of clinical trial participants. Indian Council of Medical Research (ICMR) has framed and revised the ethical guidelines from time to time, and the same are followed nationwide, both in public and private sectors. Also, in order to improve the transparency and accountability in review and approval of clinical trials, online submission and processing of such applications under the SUGAM portal has been put in place. ICMR has developed various medical technologies which have been transferred to Industry for commercialization.
Professional and technical education: The Government has introduced a common entrance examination viz. National Entrance cum Eligibility Test (NEET) for admission to all medical courses in the country through amendment in the IMC Act, 1956. The Graduate Medical Education Regulations, 1997 and Postgraduate Medical Education Regulations, 1997 and Postgraduate Medical Education Regulations, 2000 have also been amended to provide for common counseling for admission to medical course making the entire admission process transparent and merit based.
The following measures have also been taken:
Food Safety: The FSSAI, Government of India assures safe and wholesome food to the citizens of India. FSSAI is continuously setting globally benchmarked standards of food products and practices and works for consistent and transparent enforcement of these standards and practices. FSSAI has streamlined import clearance procedure to make it hassle free. It has worked towards credible food testing eco system and has launched a Central Sector Scheme with an outlay of Rs. 481.95 Crore for strengthening lab infrastructure in the country. FSSAI has worked towards capacity building and creating a culture of self-compliance to raise the bar of food safety.
Medical products: As far as medical products are concerned, the drugs, cosmetics and notified medical devices are regulated under provision of Drugs and Cosmetics Act 1940 and Rules 1945 thereunder.