1986 PLP 1610 (CLC)

Liaquat Merchant, Deputy Attorney‑General for Respondent. Date of hearing: 5th March, 1986. ABDUL QADEER CHAUDHRY, J.‑‑The petitioners had been manufacturing for sale a drug namely 'Anaroxyl' in tablet and injectable forms since 13‑1‑1968 under a permit granted by the Ministry of Health under the provisions of the repealed Drugs Act, 1940. After promulgation of the Drugs Act, 1976, the petitioners applied for and were granted registration of 'Anaroxyl' tablets. Certificate of Registration, dated 15‑8‑1976 was issued by the Registration Board. The certificate of Registration remains valid for a period of five years at a time. The petitioners thereafter applied for renewal of the registration of this drug. In their application, dated 30‑6‑1981 it was stated that under the first proviso to rule 27 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, if application for renewal is made before the period of validity of a certificate, the certificate shall continue in force until orders are passed on such application. The petitioners continued manufacturing and selling of Anaroxyl tablets. On 1st September, 1985 the petitioners received a letter, dated 25th August, 1985 cancelling the registration of the said drug. The petitioners being aggrieved by the said letter, dated 25‑8‑1985 have filed this Constitutional Petition. It is contended by the learned counsel for the petitioners that once a registration is made, it cannot be cancelled without giving a show‑cause notice. As the impugned order has been passed without affording any opportunity to the petitioners, therefore, the mandatory provision of section 7(11) has been violated. In order to determine the controversy, the order impugned in this petition is reproduced below:‑ "This is to inform you that the above‑noted application(s) was/ were considered by the Registration Board and after necessary examination of the same the said Board has decided under rule 27 of the Drugs (Licensing, Registering and Advertising) Rules, 1976, not to renew the registration of this/these drug(s) Its therapeutic efficacy is not established and it is not required in any disorder, therefore, its registration is not renewed in the public interest." The learned Deputy Attorney‑General, on the other hand, has opposed the petition and submitted that the provision of section 7(11) is not attracted in the present case as the licence of the petitioners has neither been cancelled nor suspended. We agree with the contention of the learned Deputy Attorney‑General. According to the petitioners own showing the registration was granted in 1976 and thereafter they applied for renewal in 1981. No order has been passed by the respondent on the application moved by the petitioners for renewal of licence, According to rule 27 'a certificate of registration under this Chapter, unless earlier suspended or cancelled, be in force for a period of five years from the date of issue and may, thereafter be renewed for periods not exceeding five years at a time: Provided that if application for renewal is made before the expiry of the period of validity of a certificate, the certificate shall continue in force until orders are passed on such application." In view of rule 27 a certificate remains in force till the impugned order is passed. The perusal of the impugned order shows that the registration of medicine is not renewed. Thus, it is not a case of cancellation or suspension. Under the law a licence‑holder has to apply for renewal of licence after expiry of period of registration certificate. In view of such provision, the question of show‑cause notice as contemplated under rule 7(11) does not arise at all. Rule 30 provides for renewal of licence and conditions for grant of renewal of registration. Mr. Salimuddin Ahmad Mufti has filed counter‑affidavit on behalf of respondent. In para. 6 he has stated as under:‑ "I say that the petition has no merits as the decision of the respondent was well‑thought and was taken at a meeting of the registration board held on 28th and 29th March, 1984. The case for continuation of registration of the drug in question was considered and it was decided to ask for the opinion of the experts. Accordingly the Principals of all Medical Colleges were requested to send their comments. The comments received were tabulated and considered by the Board. The issue was reconsidered in the 28th meeting of the Registration Board held on 25th June, 1985 when it was decided to not to register oral products containing Carbazodareme i.e. Carbazodareme Tablet of all the manufacturers including that of appellant. The question of renewal of registration of the Carbazodareme Injection is still under consideration for want of further examination. The decision will be taken on receipt of the expert's opinion on the subject. The appellant was informed of the decision of Registration Board that it has not granted renewal of application for registration (Annexure 'C'). This was not a case of de‑registration. In any event the rules have been amended vide SRO 6(1)/77, dated 31‑12‑1976 and there is no requirement of issuing show‑cause notice even in a case of de‑registration." The respondent has given the reasons in support of the impugned order and this .Court while exercising jurisdiction under Article 199 of the Constitution would not substantiate its own reasoning in place of the authority of competent jurisdiction. The reasoning cannot be displaced even on the ground that they are erroneous. In the instant case the respondent has based its order on certain facts which are within the exclusive domain of such authority. Another objection taken by the learned Deputy Attorney‑General is that the petitioners have not availed alternate remedy of appeal which has been provided under section 9 of the Drugs Act to the Appellate Board. According to this provision (section 9 of the Drugs Act) the Federal Government shall constitute an appellate Board to dispose of the appeal preferred against any decision of Licensing Board or the Registration Board or the Licensing Authority or a Board or Authority. The law provides an alternate remedy, which is appropriate, but the petitioners have not approached the said authority to deal the decision of the respondent on question of facts. The order impugned before us is not without jurisdiction so that an extraordinary remedy may be sought by the petitioners. The petition is dismissed as such with no order as to costs. A.A. Petition dismissed.