Judgment:
1. The respondents herein manufacture various bulk drugs including Tinidazole. They had filed the classification list No. 211/86 dated 8-7-1986 claiming the benefit of Notification No. 234/86-C.E., dated 3-4-1986 for Tinidazole in terms of SI. No. 21 thereof. The Assistant Collector of Central Excise, Bulsar approved the classification of bulk drugs under Heading 29.13 of the Central Excises Tariff Act, 1985 but denied the benefit of the Notification on the ground that it is not a bulk drug within the meaning of the explanation to the Notification as it does not conform to any pharmacopoeial standards and on the ground that the certificate issued by the Deputy Drugs Controller to the Government, produced by the respondents, was not acceptable as a substitute for the certificate from the Drugs Controller, which was the requirement of the Notification.
2. The lower Appellate authority accepted the contention of the asses-sees that the Tinidazole is mentioned in Martindale Extra Pharmacopoeia and accepted the certificate produced by them and set aside the order of the Assistant Collector and extended the benefit of the Notification.
3. The Revenue has filed E/Appeal No. 2780/90-C against this order of the Collector of Central Excise (Appeals), Bombay. The other appeal No.2796 /90-C arises out of the order of Collector of Central Excise (Appeals), Bombay sanctioning the refund claims filed by the appellants, consequent upon his order dated 21-3-1990 extending the benefit of Notification No. 234/86 to the bulk drug in question.
4. We have heard Shri J.M. Sharma, learned DR and Ms. Amrita Mitra, learned Counsel.
5. We find from the letter dated 5th June 1986 produced by the respondents before us that they had applied to the Drugs Controller of India for issue of certificate for bulk drugs as per the requirements of Notification No. 234/86. The letter reads as under :- "We are the manufacturer of following Bulk Drugs and holding a valid Drug Licence No. G/444 for bulk drugs from State Drugs Controller, State of Gujarat. As per Notification No. 234/86-C.E., dated 3-4-1986, we are required to obtain a certificate from your office stating that our following products are bulk drugs within the meaning of above Notification :- We also understand that The Indian Drugs Manufacturers' Association has also submitted a consolidated list of bulk drugs to your office.
In the meantime, we request you to kindly issue us a certificate for our above two bulk drugs so as to enable us to submit to the Central Excise Department.
We request you to kindly issue us a required certificate which will be highly appreciated." It is obviously in response to this letter that the certificate dated 27-6-1986 has been issued by the Deputy Drugs Controller, certifying that the claims of the respondents for bulk drugs including Tinidazole as manufactured under valid Drug Licence are eligible for exemption under Ministry of Finance Notification No. 234/86, dated 3-4-1986 for Central Excise duty. The lower Appellate authority has rightly held that once the Competent Authority is satisfied that Tinidazole is a bulk drug within the meaning of Bulk Drugs contained in the Explanation to Notification No. 234/86 and is normally used for diagnosis, treatment of prevention of diseases in human beings or animals and is used as such or as an ingredient in any formulation, there is no reason to hold that the drug is not a bulk drug. Further, we find that the Tinidazole is also mentioned as bulk drug in Martindale's Extra Pharmacopoeia. It also figures in 1996 Addendum to British Pharmacopoeia 1993. We also agree with the submissions of the learned Counsel that for the purpose of Notification No. 234/82 (which is also the Notification involved in Appeal No. 2796/96-C along with Notification No. 234/86), there is no requirement of production of certificate from the Drugs Controller. We therefore, hold that the benefit of Notification No. 234/82 and No. 234/86 is available appeals of the Revenue 6. While agreeing with the ld. Member (J) on her findings I feel that a point raised by the Revenue in the Appeal Memorandum needs to be settled. The point made is that the certificate dated 27-6-1986 has been signed by the Deputy Drugs Controller whereas the Notification No.234/86 requires a certificate to be signed by the Drugs Controller. Ld.
DR stressed that the Collector (Appeals) had erred in accepting this certificate for the purposes of impugned notification. To my mind this insistence is misplaced. Where reference is made to "Drugs Controller", it should be taken to mean "the Office of the Drugs Controller".
Therefore, when a senior officer like a Deputy Drugs Controller signs a certificate it should be deemed to be in terms of the impugned notification. This issue had come to the notice of the Madhya Pradesh High Court when delivering the judgment in the case of Jayant Vitamins Limited v. Union of India, 1991 (53) E.L.T. 278 (M.P.), although, it must be stated that this was not made an issue of. In this case the eligibility of certain drugs to the very notification was in question.
Following impression is taken from Para 18 of the judgment: "... Therefore, what was necessary for seeking the exemption was to obtain a certificate from the Drugs Controller to the Government of India to the effect that the product in question is a bulk drug and is used for diagnosis, treatment, mitigation, or prevention of diseases in human beings or animals and used as such or as an ingredient in any formulation. The Tahe Deputy Drugs Controller of the Government of India issued a certificate certifying the products in question along with the other drugs eligible for exemption from the duty under the Notification...." 7. Proceedings of the cited case do not show that any grievance was made to the effect that the impugned certificate was signed by a Deputy Drugs Controller and not the Drugs Controller. In this case also the outcome of this appeal would not depend upon this minor infraction.