JUDGMENT S.P. Srivastava and K.N. Sinha, JJ.
1. Heard the learned counsel for the petitioners, the learned counsel representing the respondent No. 1 as well as the learned standing counsel representing the respondent Nos. 2 and 3.
2. Perused the record.
3. The petitioner's claim to be the manufacturers of Ayurvedic medicines. They feel aggrieved by the provisions brought into force by Drugs and Cosmetics (Amendment) Rules, 2000. These rules were published in the Gazette extraordinary on 23.6.2000. but were to come into force after two years. These amendments. It is claimed, drastically amend the provisions contained in Drugs and Cosmetics Act, 1940. The notification publishing the aforesaid amended rules indicates that a draft of the proposed rules was published on 24.5.1999 inviting objections and suggestions from the public. After considering those objections and suggestions, the Central Government decided to amend the Rules and enforce the Drugs and Cosmetics (Amendment) Rules, 2000.
4. In the aforesaid circumstances, the amended rules were published in the Gazette on 23.6.2000 providing that they will come into force after two years. The learned counsel representing the respondent No. 1 has pointed out that in the aforesaid rules, it has been clearly provided that the requirement of machinery, equipments, spaces, qualifications were to be subject to the modifications at the discretion of the licensing authority and if he was of the opinion that having regard to the nature and the extent of the manufacturing operations, it was necessary to relax or alter, then in the circumstances of a particular case, he was empowered to do so. A note to this effect had been put at the bottom of the amended rules which had been published in the Gazette on 23.6.2000. The record indicates that the licensing authority had informed the petitioners about the requisite modification, etc. but the petitioners did not pay any heed. Subsequently, they had been informed by the impugned notices that the amended rules will become effective from 23.6.2002, therefore, they should make the required changes before that date.
5. The petitioners have prayed for declaring the amended rules as ultra vires so for as it relates to the petitioners. They have also prayed for the quashing of the impugned notices referred to hereinabove. It has also been prayed that the respondents may be restrained from compelling the petitioners from submitting fresh plan, etc., in view of the amended rules.
6. learned counsel for the petitioners has strenuously urged that the amended rules were wholly uncalled for and the earlier rules were more than enough to bring the protection sought for. So far as this aspect of the matter is concerned, suffice it to say that this Court cannot scan the wisdom of the Legislature. So far as regards efficiency and policy, of that the Legislature is the only Judge ; they are responsible to a court of justice for the lawfulness of what they do and of that the Court is the only Judge. It may also be noticed that before finalising the impugned rules, the concerned authority had invited objections and suggestions from the public. After due consideration of the matter, the requisite changes have been enforced as the earlier rules were found to be deficient in several aspects. The submission of the learned counsel for the petitioners in this regard is devoid of merit and is not at all acceptable.
7. Learned counsel for the petitioners has next urged that at any rate, these rules cannot be given retrospective effect and have to be taken to be prospective in nature. So far as this aspect of the matter is concerned, it may be noticed that although the amended rules had been published in the year 2000, a gap of two years had been provided between the publication of the rules and their enforcement. This gap was obviously meant to provide facility and opportunity to the existing manufacturers, to make the required changes and alterations as envisaged under the amended rules so that the object and purpose of the rules may be effectuated. It may also be noticed that to meet any undue hardship to the existing manufacturers, the licensing authority had been given sufficient discretion to grant necessary relaxation as contemplated in the note referred to hereinabove. All these things indicate that the rules were meant to be applicable to the existing manufacturers also and were to regulate the manufacturing process carried on subsequent to the date of the enforcement of the rules in accordance with the provisions contained in the amended rules. The submission of the learned counsel for the petitioner in this regard is also devoid of merit and is not at all acceptable.
8. No other point has been urged or pressed.
9. Taking into consideration the facts and circumstances as brought on record in their totality, no sufficient ground can be said to have been made out for interference by this Court while exercising the extraordinary jurisdiction envisaged under Article 226 of the Constitution of India.
10. The writ petition, being devoid of merit, is hereby dismissed in limine.