CWP No.13662 of 2008 1 IN THE HIGH COURT OF PUNJAB AND HARYANA AT CHANDIGARH CWP No.13662 of 2008 Date of decision: 4.8.2008 M/s Gold Star Pharmaceuticals, Private Limited ......Petitioner Versus State of Punjab and others ......Respondents CORAM:- HON'BLE MR.JUSTICE ADARSH KUMAR GOEL HON'BLE MR. JUSTICE RAKESH KUMAR GARG * * * Present: Mr. Vinod K. Kataria, Advocate for the petitioner. Rakesh Kumar Garg, J. 1. By way of this writ petition, the petitioner-Company has challenged the impugned order dated 19.3.2007 (Annexure P-5) passed by the Licensing Authority (under the Drugs and Cosmetics Act) Punjab, Chandigarh and order dated 7.11.2007 (Annexure P-7) passed by the Principal Secretary Health and Family Welfare, Punjab Chandigarh. 2. As per the averments made in the writ petition, the petitioner- Company was issued license for manufacturing drugs on 10.10.1997 which was renewed from time to time and was valid till 31.12.2007. The unit of the petitioner-Company was inspected on 1.9.2006 by the Officers of the CBI along with Drug Inspector and other officials. On the basis of the said inspection, a show cause notice was issued to the petitioner-Company prior to initiating any action. Reply dated 25.9.2006 filed by the petitioner- Company was found unsatisfactory and the petitioner-Company was directed to stop manufacturing the sale and distribution of the drug formulation in question. The permission to manufacture injection G- Norphine was also cancelled with immediate effect and the drug manufacturing license No.1626-B was placed under suspension for a period of three months vide order dated 13.12.2006. The manufacturing premises of the petitioner-Company were again inspected on 11.1.2007 CWP No.13662 of 2008 2 and certain deficiencies were found. A show cause notice was served upon the petitioner-Company to explain the contravention mentioned therein. Reply given by the petitioner-Company was considered and found to be unsatisfactory. Thereafter, the Licensing Authority vide order dated 19.3.2007 rejected the application of the petitioner-Company for renewal of license and also cancelled the drug manufacturing Drug License No.1626– B with immediate effect due to contravention of various provisions of the Drugs and Cosmetics Act, 1940. The petitioner-Company filed an appeal under Rule 85(3) of the Drugs and Cosmetics Rules, 1945 against the aforesaid order. The said appeal was also dismissed by the Principal Secretary, Health and Family Welfare Punjab-cum-Appellate Authority vide his order dated 7.11.2007. Hence, this writ petition. 3. We have heard Sh. Vinod Kataria, Advocate, learned counsel for the petitioner and perused the record of the case. 4. On behalf of the petitioner, it has been contended that the impugned orders have been passed illegally and against the well settled principle of law as there was no contravention of any of the provisions of the Drugs and Cosmetics Act, 1940 by the petitioner-Company. It has been further argued by the learned counsel that while passing the impugned order, the Licensing Authority has travelled beyond the show cause notice and therefore, the reply given by the petitioner-Company has not been considered in the right perspective. 5. We find no force in the contention raised by learned counsel for the petitioner. Both the Authorities under the statute have found that the petitioner was found manufacturing unethical drugs for sale and distribution which seems to be definitely meant for addiction and the petitioner-Company cannot be allowed to manufacture for sale such drugs in an unethical manner which will be a serious health hazard for the Society. The Statutory Authorities have also found that the petitioner has CWP No.13662 of 2008 3 not complied with the conditions of revised Schedule-M, condition of Rule 76 and Rule 78 of the Drugs and Cosmetics Act, 1940 and Rules, 1945. It was also found by the Authorities that the petitioner-Company was manufacturing G-Norphine Injection without maintaining their purchase records, manufacturing records and testing records as per Schedule-'U’ and sales record of this Drug in accordance with the provisions of said Act and Rules framed thereunder. It has also found that the petitioner- Company was conducting manufacturing of the Drug AVL-10ml, B.No.A- 908, A-919 and A-923 during the suspension period of licenses and the drug formation of above said batches were found under labelling and packing by the workers in the manufacturing area. No renovation or upgradation of the factory was under progress as contended by counsel for the petitioner and that the petitioner-Company has not produced any document regarding any material for alteration in the premises or plant as per provisions of rule 78(i) of the said Act. Thus, the petitioner was found to be guilty of the serious offence because he was found manufacturing for sale and distribution of various types of drugs which are meant for drug addiction. 6. In view of the above, we find no infirmity in the impugned orders passed by the Licensing Authority under the Drug and Cosmetics Act, 1940 and the Appellate Authority. 7. Dismissed. (RAKESH KUMAR GARG) JUDGE August 4, 2008 (ADARSH KUMAR GOEL) ps JUDGE