Question : Parameters of Pathological Tests

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 and the action taken/being taken by the Government against such companies and doctors along with the number of companies and doctors against whom action has been taken during each of the last three years, State-wise; and

(e) whether the Government proposes to fix the standard parameters for various diagnostic investigations and disseminate the same in public interest and if so, the details therefor?

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. 284* FOR 12TH JULY, 2019

(a)&(b) The parameters regarding results of the various pathological tests/investigation under medical services are defined in internationally accepted medical text books/ reference books. They are usually defined based on various scientific researches by subject specific international professional associations. The parameters/ reference range of lab investigation also depend upon the procedure of conducting the test in some instances. Accordingly, the parameters/ reference range of the results may vary from lab to lab depending upon the procedure followed by them. However, under Clinical Establishments Act, 2010, the Allopathic Standard Treatment Guidelines have been prescribed by the Government for 227 common medical conditions under which optimal diagnostic criteria including investigations and treatment have been defined. These prescribe reference range for some conditions for the purpose of therapeutic interventions.
(c) & (d) Department of Pharmaceuticals has received some complaints of unethical marketing practices by pharmaceutical companies. As informed by Department of Pharmaceuticals, the complaints received are forwarded to concerned Pharma Associations for necessary action as per the provisions of Uniform Code for Pharmaceutical Marketing Practices (UCPMP), as prepared by Department of Pharmaceuticals. The Managing Director/CEO of the pharma company is ultimately responsible for ensuring the adherence to the code.
Further, Clause 6.8 (Code of Conduct for doctors in their relationship with pharmaceutical and allied sector industry) of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 prohibits doctors from taking gifts, travel facilities, hospitality and cash or monetary grants from pharmaceutical and allied health sector industry. The said regulation empowers the Medical Council of India and respective State Medical Councils to award punishment to a doctor against any act in violation of code of Ethics for doctors. Such complaints are referred by MCI to the concerned State Medical Councils where the doctors/medical practitioners are registered. The MCI is an Appellate Authority.

(e) This information referred to at “a” and “b” above is already available in public domain on the website: www.clinicalestablishments.gov.in