(1.) The petitioner in this writ petition is one Hehnamann Homeo Institute, Tiruvarur, Thanjavur District, by proprietor Dr. S. Srinivasan. He has sworn to an affidavit filed in support of the Writ petition. In that affidavit he claims that he had obtained a licence to manufacture allopathic injections and homeopathic injections as well in 1948 itself in Licence Nos. 3 and 19 of 1948 in the list of which homeopathic injections were approved by the then Drug Controller of Madras State, that he himself was a qualified chemist under the said Drugs Act, that the licence was being renewed from year to year till 1951 and in the year 1951 when the licence was renewed, the wordings 'Homoeopathic' 'Injections' were removed as it was then found that it was unnecessary under the Drugs Act then, that the licence was being renewed year after year till 1959: that in the year 1966 he applied for licence for homeopathic medicines and injections to the third respondent herein, namely, Assistant State Drugs Controller, Madras-6, in or about August, 1966 and in his Memo. Ref. No. 59765-D-1/5/66 dated 10th August, 1966, the third respondent directed him to take the approval of the Drugs Controller, New Delhi in the matter; that accordingly by his letter dated 13th February, 1967, the petitioner wrote to the said Drug Controller of India requesting him to grant the permission to the petitioner Institute, to continue the manufacture of those homoeo injectules as usual and also inform the State Assistant Drugs Controller, Madras, so that he may include homoeo injectules also in the petitioner's licence; that the Drugs Controller of India by his letter dated 14th March, 1967, while requiring the petitioner to furnish the details regarding the composition, methods of test and assay of active ingredients and process of manufacture (including sterilisation) and elimination of pyrogens of injectable preparations, informed the petitioner that homoeopathic medicines as defined in the Drugs and Cosmetics Rules, 1945 as amended in 1964 did not include drugs administered by the parenteral route; that the third respondent herein, on receipt of the said communication from the second respondent herein, by his letter dated. 15th July, 1967 informed the petitioner that the manufacture and sale of homoeopathic injectibles without proper licence contravened the provisions of Section 18 (c) of the Drugs and Cosmetics Act, 1940 and that the petitioner-Institute would render itself liable for prosecution; and that from that time onwards the petitioner has stopped manufacturing these homoeopathic injectibles. The further case of the petitioner is that it was only on account of an amendment of the rules framed under the Act, called the Drugs and Cosmetics Rules 1945, in 1964, the respondents had taken this attitude; that till 1964 there was no separate definition for homoeopathic medicines in the said rules and licences granted for the manufacture of allopathic injectules were held, good for the manufacture of homoeopathic injectules also; that by the 1964 amendment, Sub-rule (dd) in Rule 2, was inserted defining, homoeopathic medicines in and by which homeopathic medicines (drugs) administered by the parenteral route alone were excluded from the definition of homoeopathic medicines: that by reason of this new amendment the petitioner had been informed by both the Drugs Controller of India and the Assistant State Drugs Controller, Madras (second and third respondents herein) that the petitioner could not get a licence for the manufacture of homoeopathic injectules. It is against the background of these allegations the petitioner contends in this affidavit that Sub-clause (dd) of Rule 2 of the Drugs and Cosmetics Rules, 1945, is violative of Articles 14 and 19 (1) (g) of the Constitution of India, in so far as it excludes drugs administered through parenteral route from the definition of homoeopathic medicines. Therefore, the petitioner prays in this writ petition for the issue of a writ of mandamus or any other appropriate writ direction or order in the nature of a writ directing the respondents herein, namely: (1) the Government of India, represented by its Secretary, Ministry of Health, New Delhi; (2) The Drugs. Controller of India, Directorate General of Health, New Delhi; and (3) The Assistant State Drugs Controller Madras-6, to issue a licence to the petitioner for the manufacture and sale of homoeopathic injections in its factory at Tiruvarur, Thanjavur District, in accordance with Rule 85-B of the Drugs and Cosmetics Rules, 1945.
(2.) Two separate counter-affidavits have been filed one on behalf of the second respondent and the other on behalf of the third respondent. As far as the second respondent is concerned, he states in his counter-affidavit that the preparations proposed to be manufactured by the petitioner fall within the definition of the term 'new drug' under the Explanation to Rule 30-A (2) of the Rules and therefore the second respondent's Department had asked for details regarding the composition, methods of test and assay of active ingredients and process of manufacture from the petitioner to consider the question of approving its manufacture as 'new drug ' as required under rule 75-B of the Rules. The further case set out in the counter-affidavit of the second respondent is that homoeopathy is based on definite principles and natural laws as laid down in the Organ on written by the founder, Dr. Samuel Hahnemann; that no individual has any right or authority to prepare homoeopathic medicines according to his own conception; that all homoeopathic medicines are required to be prepared according to the instructions given by Homeopathic Pharmacopoeia and also used according to the same manner; and that the administration of homeopathic medicines by parenteral route goes against the fundamental tenets of homoeopathy propounded by Hahnemann. The second respondent also states that the data which the petitioner was asked to supply as per his Department's letter dated 14th March, 1967, was to enable the Drugs Controller (India), to consider whether the injectible preparations proposed to be manufactured could be approved as new drug under Explanation to Rule 30-A (2) of the Drugs and Cosmetics Rules, 1945. With regard to the specific claim put forward in regard to homeopathic injections, the second respondent states that it is impossible to sterlize any injection of a potentised homoeopathic medicine since heat will affect the efficacy of the product; that sterilisation by methods other than heat, namely, filtration may result in absorption of minute amount of the active drug by the filter and alter the potency of the preparation; and that neither the Homoeopathic Pharmacopoeia nor the Homoeopathic Materia Medica has mentioned so far about the usage of homoeopathic medicines by parenteral route and as such the question of including parenteral method in the definition of homoeopathic medicines does not arise.
(3.) In the counter-affidavit filed by the third respondent herein, it is further stated that the petitioner never had a licence for the manufacture of homoeopathic injections nor did it manufacture the same. In paragraph 2 of the counter-affidavit, it is stated:
It is seen from the old licence books that no licence for the manufacture of drugs has been issued to Hahnemann Homeo Institute, Thiruvarur, but the name of the petitioner, Dr. S. Srinivasan is found as expert staff in the licences in form 25 bearing No. 64 of 1948 dated 15th March, 1948 and in form 28 bearing No. 19 of 1948 dated 26th February, 1948 issued to Biological Laboratories, Thiruvarur, and this firm was permitted to manufacture homeopathic injections also in addition to allopathic medicines. The manufacturing licences in form 25 and 28 bearing No. 31 of 1954 and 3 of 1954 both dated 1st October; 1954 subsequently issued to Biological Laboratories (P.) Ltd., Thiruvarur, were cancelled on 24th December, 1957 itself. Hence, it is submitted that the petitioner's contention in para. 2 of the affidavit that the licences were renewed up to 1966 is not correct.
In paragraph 3 of the counter-affidavit of the third respondent, it is stated:
It is submitted that the licences issued to Biological Laboratories, Thiruvarur, were of course valid up to 1950. While they applied for renewal for the subsequent period the firm themselves had not applied for continuation of permission to manufacture the item 'Homeopathic Injections.' M/s. Biological, Laboratories, Thiruvarur, was converted into a Limited concern in 1954 and the licences granted to them were surrendered by them as per their letter dated 15th November, 1957 since they were not able to comply with Schedule 'M' and were also not able to employ a suitable technical staff as per the Drugs Rules, 1945. Hence the licences were cancelled in the 3rd respondent's P. No. 235/D/57 dated 24th December, 1957.
The further case of the third respondent, as put forward in his counter-affidavit, is that the contention of the petitioner that licence was being renewed from year after year till 1965-66 is not true, as Messrs. Hahnemann Homeo Institute, namely, the petitioner, had never applied for or obtained any licence for the manufacture of drugs and that even the licences that were granted to Messrs. Biological Laboratories (P.) Ltd., Thiruvarur, were surrendered and cancelled as stated in paragraph 3 of the counter-affidavit, and therefore the contention of the petitioner that in the year 1966, it had applied for licence for homeopathic medicines and injections to the third respondent in or about August, 1966 is not correct, as the petitioner had not sent any application for the grant of a licence to the Institute. The counter-affidavit of the third respondent proceeds to state that the case of the petitioner, as set out in paragraph 5 of the affidavit of the petitioner, that the grant of licence had been refused to it for the previous years is wrong and no refusal orders had been issued so far as the application of the petitioner is still under consideration. Added to this, in the course of the arguments, it is also contended on behalf of the respondents before me that the petitioner was required to give the particulars referred to in the counter-affidavit of the second respondent and the petitioner had not so far furnished those particulars.;