Unregulated Chemicals In Diagnostics: High Court Orders Centre, State To Submit List Of NABL Accredited Path Labs Within Madhya Pradesh

While hearing a PIL concerning use of unregulated chemicals, re-agents, salts for medical diagnostics in pathological labs across the country, the Madhya Pradesh High Court has directed the Central and State authorities to provide list of pathological labs accredited to National Accreditation Board For Testing And Calibration Laboratories (NABL) within the State.

The court also asked the authorities to present a roadmap as to how they will ensure that every pathological lab running in Madhya Pradesh is accredited to NABL.

A division bench of Chief Justice Suresh Kumar Kait and Justice Vivek Jain issued the following directions:

"a) The Union of India is directed to file an affidavit mentioning the list of all the chemicals/regents/salts/kits etc used in pathological labs for diagnostic purposes and whether Indian Pharmacopoeia (Respondent No.3) has provided monograph / formulary regarding identity, purity and strength of such chemical etc.

b) The respondent No.3 shall also file an affidavit mentioning whether it has provided monograph/ formulary regarding identity, purity and strength of such chemicals, etc and if not, then what is the feasibility for providing such standards.

c) The respondents/Union of India and Authorities of State of Madhya Pradesh are directed to provide list of pathological labs accredited to NABL within the State of Madhya Pradesh and in what manner they will ensure that every pathological lab running in State of Madhya Pradesh is accredited to respondent No.9 (NABL). They will also initiate steps to ensure that such laboratories are accredited to respondent No.9 (National Accreditation Body for Certification Laboratories) in phased manner and shall intimate the steps taken for enforcing accreditation of Pathological laboratories with NABL."

The plea alleges the chemical/reagents/salts/kits as used in pathological laboratories are not being manufactured under the statutory scrutiny as to their identity, purity and strength by the statutory bodies and the organizations functioning under the aegis of the central as well as State Governments under the Drugs and Cosmetics Act 1940 and the Drugs and Cosmetics Rules 1945.

The plea alleges that the chemical/reagents/salts/kits used in pathological laboratories are also Drugs within the meaning of section 3(1) of the Act, therefore, the provisions used of the Act as well as the Rules as applicable to other drugs are applicable to the chemical/reagents/salts/kits used in the pathological labs for conducting various diagnostic tests. Thus, the petitioner emphasizes that the Indian Pharmacopoeia Commission should also issue monograph/formulary for the chemical/reagents/salts/kits used by the Pathological Labs all across the country.

For context, a monograph is a document that evaluates a drug, while a formulary is a list of drugs that are approved for use. Further, Indian Pharmacopoeia Commission (IPC) is an autonomous institution under the Government of India established to deal with matters relating to timely publication of the Indian Pharmacopoeia, the official book of standards for drug included therein, so as to specify the standards of identify, purity and strength of the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India.

The plea further alleged that the Government labs dedicated for test of medicines are accredited to NABL but none of the Pathological labs except few Government Labs are so accredited. Thus, the petitioner submitted that Pathological Labs all across the country, dealing with human lives, are not functioning as per any organization prescribing for standards.

NABL is an autonomous body under the Department of Science and Technology, Government of India established with the objective to provide Government, Industry Associations and Industry with a scheme for third- party assessment of the quality and technical competence of testing and calibration laboratories.

In the reply filed by the respondents, it is stated that the monographs of chemicals/reagents/salts/kits used in the Pathological laboratory do not pertain to mandate of Indian Pharmacopoeia Commission.

It is further stated that as per the definition of drugs under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940, only those reagents and kits notified by the Central Government in the Gazette which are used for diagnosis of disease and disorders are covered and regulated under the Act. Thus, only three diagnostic kits/device that is HbsAg, HCV and HIV are notified and regulated for import and manufacture. Other non-notified diagnostic kits are regulated as a drug by virtue of them falling under the definition of drugs as defined under section 3(b)(i). Thus, laboratory chemicals, salts and reagents for laboratory analysis are not regulated under the provisions of Drugs and Cosmetics Act.

The court has listed the matter on April 1

Case Title: Amitabh Gupta Vs Union of India And Others, Writ Petition No. 12 Of 2015