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2003 DIGILAW 823 (SC)

SIDI PHARMACY (P) LTD. v. UNION OF INDIAS

2003-07-24

ASHOK BHAN, R.C.LAHOTI

body2003
ORDER 1. THIS WRIT PETITION AND THE IA IN WP (C) NO. 3559 OF 1983, WHICH WAS DISPOSED OF BY THE ORDER DATED 1-4-1997, ARE A COROLLARY AND OFFSHOOT OF THE ABOVESAID DECISION, REPORTED AS PRATAP PHARMA (P) LTD. V. UNION OF INDIA1. PURSUANT TO THE DIRECTIONS GIVEN BY THIS COURT, A COMMITTEE, CONSTITUTED UNDER SECTION 33-C OF THE DRUGS AND COSMETICS ACT, 1940, WENT INTO THE QUESTION AND, AFTER AFFORDING THE PETITIONER AN OPPORTUNITY OF HEARING AND TAKING INTO CONSIDERATION SUCH MATERIAL AS WAS AVAILABLE TO IT, CAME TO A CONCLUSION THAT THE INJECTABLE PREPARATIONS BEING MARKETED AS AYURVEDIC INJECTIONS BY THE PETITIONER FIRM DO NOT FIND PLACE IN ANY OF THE AYURVEDIC F TEXTS AND ARE ALSO NOT LISTED IN AYURVEDIC PHARMACOPOEIA OF INDIA. AS REGARDS THE DATA TO BE FURNISHED BY THE FIRM ABOUT EFFICACY, SAFETY AND CLINICAL TRIAL OF THEIR PRODUCTS, THE COMMITTEE FORMED AN OPINION THAT SUFFICIENT DATA WAS NOT FURNISHED IN SPITE OF ADEQUATE OPPORTUNITY HAVING BEEN ALLOWED. THE COMMITTEE OF EXPERTS CONCLUDED THAT THE AYURVEDIC INJECTIONS MARKETED BY THE PETITIONER FIRM REQUIRED TO BE PROHIBITED. 2. THE SUBMISSION OF THE LEARNED SENIOR COUNSEL FOR THE PETITIONER HAS BEEN THAT THE FINDING OF THE COMMITTEE IS NOT CORRECT. IT WAS ALSO SUBMITTED THAT THE RECOMMENDATION OF THE AYURVEDIC AND UNANI SERVICE DIRECTOR, SUPPORTED BY A RECOMMENDATION OF CENTRAL TEAM AND TASK FORCE ON PHARMACEUTICALS AND KNOWLEDGE-BASED INDUSTRIES AS ALSO CENTRAL COUNCIL FOR RESEARCH IN AYURVEDA AND SIDDHA, HAS BEEN THAT A PROVISIONAL LICENCE FOR THE MANUFACTURE OF AYURVEDIC INJECTIONS DESERVES TO BE GRANTED. THE LEARNED SENIOR COUNSEL FURTHER SUBMITTED THAT OTHER COUNTRIES OF THE WORLD ARE TAKING ADVANTAGE OF THE RICH STORE OF KNOWLEDGE AVAILABLE IN INDIAN LITERATURE ON AYURVEDIC MEDICINES AND DRUGS WHILE INDIA IS LAGGING BEHIND. ALL THESE ISSUES ARE TO BE CONSIDERED BY THE GOVERNMENT OF INDIA AS ADVISED BY THE BODY OF EXPERTS. WHETHER TO PERMIT OR NOT TO PERMIT AYURVEDIC INJECTIONS IS A POLICY DECISION REQUIRING SERIOUS THOUGHT AND CONSIDERATION TO BE GIVEN TO PEOPLES HEALTH AND TREATMENT METHODS. WE DO NOT THINK THAT ADJUDICATION ON SUCH ISSUES FALLS WITHIN THE SCOPE OF JUDICIAL REVIEW AND THE JURISDICTION OF THIS COURT. THE PETITIONER IS STILL AT LIBERTY TO PURSUE ITS CASE WITH THE GOVERNMENT OF INDIA. 3. SUBJECT TO THAT OBSERVATION, THE WRIT PETITION AND THE IA ARE DISMISSED.