Question : Pathological Investigations under Medical Services

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether the Government has fixed parameters regarding results of the various pathological tests/ investigations under medical services;

(b) if so, the details thereof;

(c) whether the Government is aware that some pharmaceutical companies in collusion with doctors are selling medicines by terming the parameters fixed as wrong;

(d) if so, the details thereof along with the number of companies and doctors against whom action has been taken during each of the last three years and the current year, State/UT-wise; and

(e) other corrective steps taken/proposed to be taken by the Government in this direction?

ANSWER
THE MINISTER OF HEALTH AND FAMILY WELFARE
(DR. HARSH VARDHAN)

(a) to (e) A Statement is laid on the Table of the House.






STATEMENT REFERRED TO IN REPLY TO LOK SABHA
STARRED QUESTION NO.358* FOR 19TH MARCH, 2021

(a) and (b): The Government of India has enacted the Clinical Establishments Act, 2010 and notified Rules thereunder for registration and regulation of clinical establishments including pathological laboratories. For grant of registration, every clinical establishment is required to fulfil conditions which among others also include compliance to Standard Treatment Guidelines (STGs) issued by Centre/State Government from time to time. So far, Ministry of Health and Family Welfare (MoHFW), Government of India, has issued STGs for 227 medical conditions in Allopathy and 18 conditions in Ayurveda. Treatment guidelines have also been prescribed under various National Health Programmes. The Act, however, does not bestow mandate to fix parameters regarding results of various pathological tests/investigations under medical services. In fact such parameters are usually defined by consensus of medical experts or professional associations, based on outcomes of clinical studies and are usually prescribed in standard medical textbooks on the respective subjects.

(c) to (e) No such incidence has been reported to Ministry of Health and Family Welfare.