Back
2025 Supreme(Online)(MP) 1220
HIGH COURT OF MADHYA PRADESH
AMITABH GUPTA – Appellant
Versus
UNION OF INDIA – Respondent
WP No. 12/2015
The court clarified that while certain diagnostic kits are regulated under the Drugs and Cosmetics Act, laboratory chemicals are not, emphasizing the need for proper accreditation of Pathological Labs.
Headnote:(A) Drugs and Cosmetics Act, 1940 - Sections 3(b), 16; Drugs and Cosmetics Rules, 1945 - The petitioner sought inclusion of chemicals used in Pathological Labs in the Pharmacopoeia and verification of their standards. The respondents stated that only specific diagnostic kits are regulated under the Act, while laboratory chemicals are not. (Paras 2-9)
(B) Regulatory Framework - The court emphasized the need for standards for medical devices and diagnostics, noting that the Indian Pharmacopoeia Commission is responsible for setting these standards. (Paras 3-8)
Facts of the case:
The petitioner requested the court to ensure that only chemicals meeting prescribed standards are used in Pathological Labs, arguing for the inclusion of various reagents in the Pharmacopoeia. The respondents clarified the scope of regulation under the Drugs and Cosmetics Act, indicating that only certain diagnostic kits are covered.
Findings of Court:
The court directed the Union of India to provide a list of chemicals used in Pathological Labs and the Indian Pharmacopoeia's role in standardizing these substances. It also mandated the accreditation of Pathological Labs by the National Accreditation Body for Testing and Calibration Laboratories (NABL).
Issues: The main issues included the regulation of chemicals used in diagnostics, the role of the Indian Pharmacopoeia in standardization, and the accreditation of Pathological Labs.
Ratio Decidendi: The court found that while the Drugs and Cosmetics Act regulates certain diagnostic kits, laboratory chemicals are not covered, and emphasized the importance of accreditation for ensuring quality in medical diagnostics.
Result: The Union of India is directed to file an affidavit regarding the chemicals used in Pathological Labs and their standardization within a month.
ORDER
By way of this writ petition, the petitioner has sought the following reliefs:-
“(i) The respondent No. 3 to include the chemical/reagents/salts/kits used by the Pathological Lab for diagnosis of a disease in the Pharmacopoeia and prescribe/prepare monograph/formulary fixing the identity, purity, and strength therefore as per the requirement of Section 16 of the Drugs and Cosmetics Act, 1940 and Rule 124 of the Drugs and Cosmetics Rules, 1945 .
(ii) The respondent No. 2, 4, 5, 6 and 7 to conduct tests/verification of the chemical/reagents/salts/kits manufactured in India as well as imported to India, as per the monograph/formulary prescribed by the respondent No. 3.
(iii) The respondent No. 1 & 8 to ensure in a phased manner that no chemical/reagents/salts/kits is being used by the Pathological Labs in the other states of the country as well as in the State of M.P. except those manufactured as per the standards prescribed by the respondent No. 3.
(iv) The respondent No. 1 and 8 to take necessary steps in a phased manner to ensure that every pathological Lab running in the territory is accredited to respondent No. 9.
(v) The respondent No.1&8 to take necessary steps to ensure that no manufacturer should manufacture nor any Importer should Import any chemical/reagents/salts/kits to be used in Pathological Labs except of the standards prescribed by the respondent No.3 and verified by the respondent No. 4,5 and 6.
(vi) The respondents to furnish report before the Hon'ble Court with respect to the steps taken by them in relation to the aforementioned reliefs sought by the Petitioner in a phased manner till the provisions of the Act as well as the Rules are complied with in toto.
(vii) Any other relief which the Hon'ble Court deems fit in the facts and circumstance of the case.”
(2) The reply filed by the respondents No. 1,2 ,4 and 5 is on record whereby it is stated that the Drugs and Cosmetics Act, 1940 (Act hereinafter) along with the Drugs and Cosmetics Rules, 1945 (Rules herein after), made there under is a legislation with an objective to regulate the import, manufacture, distribution and sale of drugs and cosmetics while preventing the spurious, adulterated and substandard drugs to be imported, manufactured, distributed and sold in the country. The avowed objective of the Act is to ensure the safety, efficacy and the quality of the drugs being imported, manufactured, distributed and sold in the country. Section 16 of the Act mentions about standard of quality and the same is reproduced hereunder:
16. Standards of quality.—(1) For the purposes of this Chapter, the expression “standard quality” means—
(a) in relation to a drug, that the drug complies with the standard set out in the Second Schedule, and (b) in relation to a cosmetic, that the cosmetic complies with such standard as may be prescribed.
(3) That in reply to the contents of paragraph Nos. 3.4 to 3.8, it has been stated by the respondents that Indian Pharmacopoeia Commission is an autonomous institution under the Ministry of Health and Family Welfare, Government of India. It deals with matters relating to timely publication of the Indian Pharmacopoeia which is the official book of standards for drugs, in terms of the second schedule of the Drugs and Cosmetics Act, 1940 so as to specify the standards of identity, purity and strength for the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India. With the above objective in view, the Indian Pharmacopoeia Commission (IPC) was registered as a society under the Societies Registration Act, 1860 under the Ministry of Health and Family Welfare, with the mandate to perform, inter alia, functions such as revision and publication of the Indian ‘Pharmacopoeia and the National Formulary of India on a regular basis.
(4) It is further stated that Section 16 of the Act mentions about standard of quality and the same is reproduced hereunder:
16. Standards of quality.—{1) For the purposes of this Cha
