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2003 Supreme(Pat) 634

PATNA HIGH COURT
Aftab Alam, J.
Universal Drug House Private Limited
Versus
State Of Bihar
Civil Writ Jurisdiction Case No. 5178 of 2003 ;
Decided On : JUNE 30, 2003

Headnote:Drugs & Cosmetics Rules, 1945-Rule 66-Cancellation of Drug Licences-Petitioners drug licence cancelled in its entirely on the ground of irregularities with regard to two items-Combining allopathic compounds with Ayurvedic ingredients and fixing higher retail price-It is true that a single violation of the licence or a contravention of the licence with regard to any of the items covered by it may be so grave and serious as to justify the cancellation of entire licence with regard to a number of other items as well, but all violation may not necessarily lead to cancellation of the licence as whole-A technical or minor violation in regard to one or some of the items covered by the licence may not, in all cases, justify cancellation of the whole licence covering many other items in regard to which there is no violation of any kind-It cannot" be lost sight of that the cancellation of the licence in its entirety would amount to a forcible shutting down of a long standing business of the licence-The power to cancel licence must be exercised with proper discretion and not mechanically or arbitrarily-In the facts and circumstances of the present case the irregularities alleged against the petitioner with regard to the two specified items under its licence do not appear so grave or serious as to render the entire licence liable to cancellation and the impugned order to that extent is quashed-With regard to cancellation of the licence in respect of said two specified items petitioner permitted to prefer appeal-Writ petition allowed.

       2002(3) PLJR 580-Relied upon.

Judgment

1. The petitioner is a company engaged in manufacture, sale and distribution of drugs, medicines and pharmaceutical products. It has its manufacturing unit in West Bengal where it holds a licence to manufacture drugs for sale issued by the Director of Drugs Control, West Bengal. The petitioner has its sale out-let(s) in this State and it holds a licence to sell, stock or exhibit or offer for sale or distribute drugs issued by the Regional Licensing Authority inthis State. The licence permits the petitioner to sell, stock etc. 51 different items indicatedin the licence.

2. This writ petition is filed challenging the order passed by the licensing authority (the Regional Licensing Officer, Drugs Control Administration, Patna Division, Patna) under his memo No. 674, dated 20-5-2003 (Annexure 4) cancelling the licence issued to the petitioner. The cancellation order is passed in exercise of power under Rule 66 of the Drugs & Cosmetics Rules, 1945.

3. The petitioner was given a show cause notice, dated 12-4-2003 (Annexure 3) with regard to certain irregularities found in course of an inspection of its business premises on that date. The irregularities in regard to which the petitioner was directed to show cause were with reference to two specific items out of the 51 items covered by its licence. One was a patent syrup called Ocimal Linctus with Codeine and the objection of the Drug authorities was that in the preparation of this syrup two Ayurvedic in gredients, namely, Vasaka and lobelia were also used in combination with Allopathic compounds. A combination of allopathic compounds with Ayurvedic, Sidha or Unani ingredients was prohibited in terms of a notification, dated 23-7-1983 issued by the Central Government under Sec. 26-A of the Drugs and Cosmetics Act. The other irregularity in regard to which the petitioner was asked to show cause was with reference to the sale price of Parafen tablets. In Bihar the maximum retail price of these tablets was fixed at Rs. 6.04 paise plus excise duty for a leaf of ten tablets. But the packed strips of the tablet found at the petitioners premises had Rs. 10.00 printed as the maximum retail price of each leaf of ten tablets.

4. The petitioner gave its reply to the show cause on 23-4-2003. In the show cause, it was stated with regard to Ocimal Linctus with Codeline that in the licence, dated 23-12-1992 issued by the Drugs Controller, West Bengal (for manufacture of drugs), this preparation with Vasaka and lobelia as its ingredients was included in the list of approved medicines. It was further stated that a renewed drug licence (upto 31- 12-2006) was received by the petitioner on 17-2-2003 in which this preparation was deleted and the petitioner had made an application for a fresh licence omitting vasaka and lobelia from the formula of the preparation and it hoped to get the necessary permission within a week from the date of filing of the show cause. It was further stated that the patent syrup found in course of inspection was manufactured before the issuance of the renewed licence on 17-2-2003. The petitioner further expressed its willingness to withdraw the stock from sale in this State and to take it back to West Bengal where the sale of this preparation was not prohibited.

5. As regards Parafen tablets, a plea was taken that the cost of production was higher than the maximum retail price fixed by the State Government and the petitioner was willing to withdraw these tablets from sale in Bihar and to send them back to West Bengal for sale there.

6. The licensing authority found the petitioners explanation unsatisfactory and consequently issued the impugned order cancelling the petitioners licence in its entirety.

7. Opposing the writ petition Mr. J. D. Singh, G.P.I., submitted at the out-set that rule 66(2) provided for an appeal against an order of cancellation of licence. He submitted that it was open to the petitioner, in terms of rule 66(2), to file an appeal against the impugned












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