Home  |  News  |  Sitemap  |  Contact Us  |  Login
Advertise With Us
Latest Notification
  • banner1
  • banner2
  • banner3
  • banner4
  • banner5
  • banner6
  • banner7
banner11 banner22 banner33 banner44 banner45 banner46 banner47

 Case Digest


Back
Drugs and Cosmetics Rules, 1945
Rules 76 and 78—non-compliance of—manufacture of unethical drugs—meant for addiction
Rules 76 and 78—non-compliance of—manufacture of unethical drugs—meant for addiction
Non-compliance of—manufacture of unethical drugs—meant for addiction - Rules 76 and 78—non-compliance of—manufacture of unethical drugs—meant for addiction the permission to manufacture injection G- Norphine was 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 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—Drugs licence cancelled—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 petitioner has not complied with the conditions of revised Schedule-M, condition of Rule 76 and Rule 78 of the Drugs & 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—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—no infirmity in the impugned orders passed by the Licensing Authority under the Drugs & Cosmetics Act, 1940 and the Appellate Authority.
M/s Gold Star Pharmaceuticals Pvt Ltd vs. State of Punjab and others, Punjab and Haryana High Court, 2009 (1) Drugs Cases (DC) 289

Back


» Home
» Latest Notification
» New Drugs
» Import of Drugs
» Drug Prices
» Legislations
» Applications Forms
» Quackwatch
» Forms & Fees
» Licence Conditions
» Schedules
» Health, Pharma. Policies & Reports
» Ayurvedic
» Govt. Bodies
» Information Centre
» Directory
» Alert
» Regulatory News
» Research News
» News in Hindi
» Login
» Contact Us

Copyright © DrugsControl.org - Jaipur, INDIA. All Rights Reserved   |   Disclaimer   |   Sitemap

Site last updated: December 30, 1899 at