KAPIL KAUL Vs. UNION OF INDIA

JUDGEMENT

(1.) This petition filed by the petitioner in his individual capacity, was treated as Public Interest Litigation by the learned Single Judge vide order dtd. 7/6/2024.

(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 and Naturopathy, Unani, Siddha and Homoeopathy of Government of India, Ministry of Health and Family Welfare, New Delhi (hereinafter referred to as 'AYUSH') has issued a Govt. Order dtd. 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 1/1/2006. Similarly, this process of self-certification was extended for sale within the country. Thereafter, the Department of AYUSH issued another Notification dtd. 9/9/2008 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 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 dtd. 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: