Jammu & Kashmir High Court
Kapil Kaul vs Union Of India And Others on 4 July, 2025
Author: Rajnesh Oswal
Bench: Rajnesh Oswal
HIGH COURT OF JAMMU &KASHMIR AND LADAKH
AT JAMMU
Reserved on :28.05.2025
Pronounced on: 04.07.2025
Case: WP(C)PIL No. 3/2024
Kapil Kaul.
...Petitioner(s)/Appellant(s)..
Through:-Mr. Rupinder Singh, Advocate for petitioner.
Mr. Anil Verma, Advocate for Intervener.
V/s
Union of India and others.
Through:- Mr. S. S. Nanda, Sr. AAG with
Mr. Sumant Sudan, Assisting Counsel to
Mr. Vishal Sharma, DSGI
CORAM: HON'BLE THE CHIEF JUSTICE
HON'BLE MR. JUSTICE RAJNESH OSWAL, JUDGE
JUDGMENT
PER OSWAL-J:
1. This petition filed by the petitioner in his individual capacity, was treated as Public Interest Litigation by the learned Single Judge vide order dated 07.06.2024.
2. The grievance projected by the petitioner in this petition is in respect of presence of heavy metals like Arsenic, Lead, Mercury and Cadmium in Ayurveda, Unani and Sidha drugs. It is stated that Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy of Government of India, Ministry of Health and Family Welfare, New Delhi (hereinafter referred to as "AYUSH") has issued 2 WP(C)PIL No.3/2024 a Govt. Order dated 14.10.2005, which makes it mandatory that every drug meant for export, is tested for heavy metals like Arsenic, Lead, Mercury and Cadmium and further that the company will have to display the words "Heavy Metals within permissible Limits"conspicuously on the container of purely herbal Ayurveda, Siddha and Unani drugs to be exported. This order was made mandatory with effect from 1st January, 2006. Similarly, this process of self-certification was extended for sale within the country.
Thereafter, the Department of AYUSH issued another Notification dated 09.09.2008 thereby directing all the procurement agencies under the State Government/Central Government including Central Government Health Scheme (CGHS) that the supply of AYUSH medicine should be accompanied with batch-wise quality analysis from Government approved//NABL Accredited Laboratory in respect of each medicine. Further, the analytical report must be based on pharmacopeial standard and WHO/India Pharmacopoeia's permissible limit for heavy metals, Afla-toxins and Microbial contamination.
3. The cause which prompted the petitioner to file this petition as projected by him is that he had visited the Regional Ayurvedic Research Institute Ban Talab, Jammu, for consultation and treatment of his ailment. The petitioner was prescribed number of drugs including Arogya Vardhani Gutika, which was dispensed by respondent No.5 and manufactured by Indian Medicines Pharmaceutical Corporation Ltd. Mohan Uttarakhand. The label appended to the drug displayed Mercury, as one of the ingredients, 3 WP(C)PIL No.3/2024 but, there was no display of the words 'heavy metals within permissible limit' on the label of the container. The petitioner, accordingly, got the said medicine, i.e., Arogya Vardhani Gutika tested from Indian Institute of Integrative Medicines, a unit of CSIR. To the utter surprise of the petitioner, the report dated 20.12.2023 issued by Indian Institute of Integrative Medicines reflected the content of "mercury" more than 100 mg per kg whereas the permissible limit as per the ASU pharmacopeia is 1.0 only. Besides, another heavy metal namely "Arsenic" though not displayed on the label of the said drug was also found in the same drug in huge quantity, i.e. 14.2 mg per kg as against the permissible limit of 3.0 only as per ASU. By placing these facts before this Court, the petitioner has prayed for the following reliefs:
I. Writ of mandamus commanding the Ministry of AYUSH to ensure availability of safe, effective, well documented all ASU&H Medicines as human beings are not guinea Pigs and regarding said concern, the so Department of "AYUSH" Government of India had issued a directive dated 09.09.2008 to all State Health Secretaries and other including Director Central Government Health Scheme where it was made mandatory that every ASU Medicine shall accompany quality analysis report from Government Approved/NABL Accredited Laboratory/ies regarding status of heavy metals and other contaminants but is not being carried out in its letters and spirits for which a command as prayed is required to be issued.
II. Writ of Mandamus commanding the Ministry of AYUSH to ensure that all the ASU&H drugs which are being supplied to various institutions in the country by the Government permitted manufacturers must contain endorsement of "Heavy Metals within Permissible Limits" as was directed by Government in its order dated 14.10.2005 after WHO raised alarm about Ayurvedic drugs containing heavy metals beyond permissible limits in order to ensure availability of safe, effective, well documented all ASU & H Medicines lest manufacturer should be booked and no drug 4 WP(C)PIL No.3/2024 should be allowed to reach Government institutions and human being made to consume such drugs.
III. Writ of Mandamus commanding the Ministry of AYUSH to ensure that all the ASU&H drugs shall carry documentary evidence of safety and effectiveness as directed by the Government in its various communications from time to time along with batch wise test report as also directed in communication dated 09.09.2008 issued by the Department of AYUSH, Government of India.
IV. Writ of Mandamus commanding the Ministry of AYUSH or any other concerned department to fix accountability as to how come the Stores Officers/Managers accepted the drugs manufactured by third party on loan license basis in the name of the supplier which is a big scam and the recovery from the officers who accepted such drugs which further contained heavy metals beyond permissible limits shall be initiated so that erring officers who have shown least concern about human lives and have allowed consumption of Ayurvedic drugs containing heavy metals beyond permissible limits should be booked and proceeded for such vital lapses. V. Writ of Mandamus commanding the Ministry of AYUSH to ensure that all AYUSH medicines should carry documentary evidences of safety and effectiveness along with the batch-wise test report as stated in Order dated 14.10.2005 meant for export and is a part of Drugs and Cosmetic Act, 1940 to be extended to domestic market with immediate effect as we are living in the scientific era, and we have traditional knowledge in the shape of Ayurveda, its numbers of drugs found to contain heavy metal beyond permissible limits which violates the basic principle of the constitution where Right to Health is a fundamental right and as such the respondents in particular the Ministry of AYUSH should be directed to ensure that every label of the drug should display in bold letters "Heavy Metal within permissible limits".
VI. Writ of Mandamus commanding CBI to investigate the financial irregularities which includes purchase of drugs containing heavy metals beyond permissible limits after 09.09.2008, purchase of drugs from Public Sector Undertakings when the purchase preference stands abolished after Apex Court judgment on 31.03.2011 and purchase of Ayurvedic drugs from Loan License Companies, an attempt to compromise on quality at the cost of exchequer by State Government/Central Government including Central Government Health Scheme.
5WP(C)PIL No.3/2024
4. Respondent No.3 has filed the response stating therein that Ayurvedic Medicines are procured by the UT of J&K by floating tenders in the open market through J&K Medical Supplies Corporation wherein all the eligible bidders throughout the country participate and the successful bidders, as per the terms and conditions of the tender, are selected. Pre-bid meeting is held as per schedule in which technical experts from Directorate of AYUSH, Officers of J&K MSCL and experts from Drugs and Food Control Organization, J&K apart from prospective bidders participate. The supply of each batch of AYUSH medicines is received with NABL accredited lab reports containing limits of heavy metals, microbial loads and Aflatoxins which are mandatory as per the guidelines of AYUSH Ministry. Further, JKMSCL also gets the medicines tested from empanelled labs where all the above-mentioned tests are conducted and supplies are distributed only if all the parameters are within the permissible limits. It is further stated that it is mandatory for the manufacturers to adhere to the prescribed requirements for licensing of manufacturing units of medicines including proof of safety and effectiveness, compliance with the Good ManufacturingPractices (GMP) as per Schedule-T and Schedule M-1 of Drugs and Cosmetics Rules, 1947 and quality standards of drugs given in the respective pharmacopoeia. Further, the State Drugs Controller, J&K has been notified as the Licensing Authority for grant of licenses for manufacturing of drugs falling under the purview of Ayurveda and Unani respectively, after securing due diligence to the mandate of Schedule-T of Drugs & Cosmetics 6 WP(C)PIL No.3/2024 Act, 1940. There are fifteen small scale AYUSH manufacturing units out of which nine are Ayurvedic units and other 06 are Unani units. These 15 small scale/micro AYUSH units have been granted licenses subject to certain conditions in particular that the manufacturer shall secure due diligence to ensure that the final product/formulation is manufactured strictly as per the validated manufacturing processes and meets with the desired quality parameters.The finished product is released for sale only after obtaining satisfactory reports from authorized laboratories regarding presence of Afla-toxins, microbial and heavy metals.
5. Short counter-affidavit has been filed on behalf of respondents 1,4 and 5 wherein it is contended that the Arogya Vardhani Gutika is an Ayurvedic formulation from authoritative classical literature of Ayurveda included in the First Schedule of Drugs and Cosmetics Act, 1940. The formulation of Arogya Vardhani Gutika contains Mercury as one of the ingredients. Besides, Arogya Vardhini Gutika includes ingredients such as Shuddha Gandhaka, Loha Bhasma, Abhrak Bhasma, and Tamra Bhasma. These components are processed through traditional methodologies, specifically shodhana (purification) and Marana (incineration) to ensure their safety and therapeutic efficacy for human consumption. It is further stated that Ministry of AYUSH, i.e., respondent No.1 has issued an advisory in accordance with communication dated 08.12.2023 which clarifies that the permissible limits of heavy metals do not apply to Ayurvedic, Siddha or Unani formulations where such metals are utilized as ingredients or 7 WP(C)PIL No.3/2024 in the processing of the formulation. This advisory clarifies the regulatory framework applicable to Arogya Vardhini Gutika, in accordance with Section 3(a) of the Drugs and Cosmetics Act, 1940, which defines Ayurvedic drugs, and Section 33-E, which empowers the government to regulate the use of ingredients in such formulations. The respondents have further mentioned the labelling, packing and limit of alcohol requirements in Ayurvedic including Siddha or Unani Drugs. Besides, it is stated that the analysis conducted by CSIR- Indian Institute of Integrative Medicine lacks validity because the Institution is not recognized as an approved Lab under the Drugs and Cosmetics Act, 1940, especially under Section 3 (b) of the Act, which defines the parameters for approved Laboratories authorized to conduct drug testing and the report of Indian Institute of Integrative Medicine cannot be relied upon, inter alia for the reasons: analysis report explicitly states that it is intended for private use and does not constitute an official analysis of drugs manufactured under the pertinent regulations, as stipulated in Section 25 of the Drugs and Cosmetics Act, which requires that analysis should be conducted by authorized laboratories for regulatory compliance; an independent analysis conducted by the Indian Medicines and Pharmaceutical Corporation Limited (IMPCL) on the same batch (19-AVG-LDA-933) on January 24, 2024 confirmed the absence of heavy metals i.e. Lead, Arsenic and Cadmium. Mercury, being an ingredient of Arogya Vardhini Gutika is exempted from testing as per advisory issued by the Ministry of AYUSH vide communication No. K-11023/01/2012- 8 WP(C)PIL No.3/2024 DCC (Ayush) dated 08.12.2023. It is also stated that the petitioner is the proprietor of M/s Biotec Pharma, Jammu. A proceeding has been initiated against the petitioner for manufacturing spurious cosmetics under Section 27-A of the Drug and Cosmetics Act, 1940, Rules of 1945 and the matter is pending before the Court of learned Chief Judicial Magistrate, Jammu. It is also stated that the petitioner is an approved chemist for an Ayurvedic manufacturer-M/s Rahul Pharma, whose product Capsule S-Compound was found as misbranded and spurious medicine regarding which matter is pending before this Court in WP(C) 970 of 2023. It is further averred that a writ petition has been filed by the petitioner with malafide intention to damage the reputation of respondent No.1 and its organizations.
6. The petitioner has filed rejoinder to both the counter affidavits filed on behalf of respondents 1,4 and 5 and respondent No.3. In reply to the counter-affidavit filed on behalf of respondents, 1,4 and 5, the authority to file counter-affidavit by the other answering respondents on behalf of respondent No.5 has been disputed by the petitioner and further reliance has been placed upon the judgment of the Hon'ble Supreme Court of India in case M/s Indian Medicines Pharmaceuticals Corporation Ltd. Vs. Kerala Ayurvedic Co-operative Society Ltd. and others, Civil Appeal No. 6693 of 2022, rendered on 03.01.2023 wherein it has been categorically stated that no procurement on nomination basis would be made, therefore, drugs, if any, procured on nomination basis as has happened in the present case clearly amounts to defiance of the above mentioned judgment of the Hon'ble Apex 9 WP(C)PIL No.3/2024 Court. In respect of communication dated 08.12.2023, it is stated that the respondents are favouring blue eyed Companies at the cost of exchequer and safety of consumers of such drugs. The above communication was in violation to Rule 158-B of Drugs and Cosmetics Rules, 1945 and communication dated 16.09.2014, which state that every Patent/Proprietary drug has to carry proof of effectiveness and safety. All Health/Ayush Secretaries and all State Licensing Authorities are required to strictly follow Rule 158-B of Drugs and Cosmetics Rules, 1945 and communication dated 09.09.2008. It is further stated that the issue is of purity and genuineness of the drugs and the respondent No.5 owes an explanation for its role and inefficiency at the cost of health of a common man in procuring the above referred medicine, i.e. Arogya Vardhini Gutika containing heavy metals beyond permissible limits and that too on nomination basis without test analysis. In the rejoinder, the petitioner has admitted the proceedings initiated against him before the court of Learned Chief Judicial Magistrate, Jammu.
7. In the rejoinder filed by the petitioner in response to the reply filed by respondent No. 3, much stress has been laid upon the guidelines dated 09.09.2008.
8. During the pendency of this petition, one Virender Mahajan of M/s Rahul Pharma, Jammu, who is a manufacturer of Anti-Arthritis Drug "S-Compound" and also the President of Ayush Drugs Manufacturers was impleaded as intervener by this Court vide order dated 12.03.2025.
10WP(C)PIL No.3/2024
9. Heard learned counsel for the parties and perused the record.
10. The grievance projected by the petitioner in this petition is in respect of presence of heavy metals like Arsenic, Lead, Mercury and Cadmium in Ayurveda, Unani and Sidha drugs and to ensure compliance of order dated 09.09.2008 issued by the Department of AYUSH and other orders issued from time to time.
11. This Court vide order dated 23.10.2024 after taking note of order dated 09.09.2008 issued by the Department of AYUSH, non- compliance of which has been reported by the petitioner, directed respondent No.3 to file detailed affidavit stating therein as to whether the directions issued vide order dated 09.09.2008 have been implemented or not and what steps have been taken till today by the respondents. Pursuant to the order mentioned above, respondent No.3 has filed an affidavit stating therein that as per the information obtained from J&K Medical Supplies Corporation, every batch of the medicines supplied under the rate contract finalized by JKMSCL is accepted only, if it is accompanied by the test reports from NABL accredited Labs/Department of AYUSH approved labs, in accordance with the extent terms and conditions of NIT, which is in compliance to D.O./No/K//11023/5/2024-DCC(Ayus) dated 09.09.2008 and the provisions for obtaining analytical reports of the drugs to be procured from the manufacturers are already included in the tender documents. Moreover, every medicine supplied is further tested by JKMSCL from NABL accredited & empanelled Laboratories before its release to the end-user for the patient consumption. It is further stated that the 11 WP(C)PIL No.3/2024 Directorate of AYUSH has also informed vide communication dated 22.11.2024 that even though AYUSH Medicines are procured and supplied by JKMSCL, however, few urgently required AYUSH Medicines (not available with JKMSCL) are procured as per the guidelines of the Ministry of AYUSH, Govt. of India and some Ayush Nutritional supplements as recommended by the Ministry of Women and Child Development and Ministry of Ayush, are procured after following all the codal formalities through e-tendering. The relevant part of terms and conditions of the tender document lastly floated by the Directorate dated 25.02.202, has been reproduced in the affidavit, which is extracted as under: -
"Further, testing of each batch of every supplied medicine shall be carried out by the Directorate of Ayush J&K from any of the NABL or Govt. of India/Department of Ayush approved Labs. Payments will be released only after satisfactory testing report regarding the drug contents and other laid down standards/norms is received from NABL or Department of Ayush or Govt. of India approved Laboratory after deducting the actual fee of test.
Each and every medicine to be supplied by the firm should have a test report from NABL or Govt. of India Laboratory/Department of Ayush showing the level of heavy metals present in the product i.e. whether the level of heavy metals present in the medicines within the admissible limits. The tenderer shall have to submit the certificate from NABL or Govt. of India/Department of Ayush approved Laboratory showing absence of aflatoxins and microbial load carrying capacity of the end product of each medicine, for the public use to be quoted. The supply of drugs/medicines shall have to be accompanied with batch- wise quality analysis report from NABL accredited Laboratory or Govt. of India/ Ayush approved Laboratory along with undertaking regarding genuineness, purity of ingredients of the product and also to the effect that the manufacturer/firm shall be responsible for quality of the product in all respects."
12. Respondent No.3, through the medium of affidavit has clearly stated that the order dated 09.09.2008 issued by the Department of AYUSH is being followed.
12WP(C)PIL No.3/2024
13. So far as the grievance of the petitioner with regard to the presence of heavy metals like Arsenic and Mercury in the drug allegedly procured from respondent No.5 is concerned, respondent No.1 has stated that as per Notification dated 08.12.2023, requirement of mentioning of the permissible limit of heavy metals on the label of drug/medicine does not apply to Ayurveda, Siddha, or Unani formulations where such metals are utilized as ingredients or in the processing of the formulations. Further the report placed on record by respondent No.1 in respect of medicine/drug in question clearly demonstrates that Lead, Arsenic and Cadmium were not detected in the same. It is also stated by the respondent No.1 that the report relied upon by the petitioner issued by Indian Institute of Integrative Medicine cannot be relied upon to demonstrate that the medicine/drug in question contained Arsenic, as the same is not approved laboratory and the report was issued only for private purpose.
14. Once respondent No.3 has filed an affidavit that the order dated 09.09.2008 issued by the Department of AYUSH is being complied with, there is no need to continue the proceedings in this petition.
15. Before parting, we would like to observe that the petitioner in his petition had nowhere pleaded that he had any concern with M/S Biotic Pharma, Jammu and was one of the accused in a complaint titled "Union of India Vs. Ms. Biotec Pharma and others" pending before learned Chief Judicial Magistrate, Jammu. Rather, he portrayed himself as gullible consumer of ayurvedic drug having heavy metals beyond permissible limits. The record further depicts that the 13 WP(C)PIL No.3/2024 application preferred by the petitioner for dropping the proceedings, was dismissed by the learned Chief Judicial Magistrate, Jammu vide order dated 26.11.2019. The petitioner undoubtedly has concealed the material facts from the court, and there is nothing on record that the petitioner was prescribed such drug by respondent No.5 and has also not denied that he is approved chemist of M/S Rahul Pharma, whose proprietor subsequently was allowed to intervene. It appears that the writ petition was filed by the petitioner in furtherance of business interest.
16. Though this petition deserves to be dismissed with exemplary costs as the petitioner has concealed the material facts with regard to his status as Prop. of M/s Biotec Pharma, Jammu and facing trial before the learned Chief Judicial Magistrate, Jammu, but taking a lenient view of the matter, proceedings in this PIL are closed with a caution to the petitioner to be careful in future and refrain himself from indulging in such type of litigation with ulterior motive.
(RAJNESH OSWAL) (ARUN PALLI)
JUDGE CHIEF JUSTICE
Jammu :
04.07.2025
'Madan Verma-Secy"
Whether the order is speaking :Yes/No
Whether the order is reportable :Yes/No
MADAN LAL VERMA
2025.07.11 19:18
I attest to the accuracy and
integrity of this document