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High Court of Judicature at Madras
V. RAMASUBRAMANIAN
Macleods Pharmaceuticals Limited & Another
Versus
Union of India, Rep.by its Secretary, Ministry of Health and Family Welfare FDA Bhavan & Another
Writ Petition Nos.21933 And 25442 Of 2011 And M.P.Nos.1, 2 And 2 Of 2011
Decided On : 26-04-2012
The impugned notification issued by the Union of India, Ministry of Health and Family Welfare, imposing a ban on the manufacture, sale and distribution of a drug by name "Gatifloxacin" was challenged by the petitioners. The petitioners contended that the impugned order was passed under Section 26A without consulting or taking any advise from the Drugs Technical Advisory Board (DTAB) and that the requirement to act as per the advise of the DTAB is a safeguard inbuilt into Section 26A, in order to avoid any arbitrary exercise of a sweeping power conferred upon the Central Government. The Court held that the power exercised by the Central Government under Section 26A is primarily legislative in nature and hence, the principles of natural justice have no role to play. The Court further held that the impugned notification, issued on the basis of the recommendations of an expert committee, cannot be found fault with on the ground that no opportunity was given to the manufacturers. The Court also held that the decision taken by the Sub-committee comprising of 10 experts, on the basis of the material indicated in para 100 above, is sufficient to satisfy the precautionary principle and hence the impugned order of the Central Government cannot be interfered with.
Fact of the Case:
The petitioners challenged the impugned notification issued by the Union of India, Ministry of Health and Family Welfare, imposing a ban on the manufacture, sale and distribution of a drug by name "Gatifloxacin".
Finding of the Court:
The Court held that the power exercised by the Central Government under Section 26A is primarily legislative in nature and hence, the principles of natural justice have no role to play. The Court further held that the impugned notification, issued on the basis of the recommendations of an expert committee, cannot be found fault with on the ground that no opportunity was given to the manufacturers. The Court also held that the decision taken by the Sub-committee comprising of 10 experts, on the basis of the material indicated in para 100 above, is sufficient to satisfy the precautionary principle and hence the impugned order of the Central Government cannot be interfered with.
Issues: 1. Whether the impugned order was passed under Section 26A without consulting or taking any advise from the Drugs Technical Advisory Board (DTAB)? 2. Whether the requirement to act as per the advise of the DTAB is a safeguard inbuilt into Section 26A, in order to avoid any arbitrary exercise of a sweeping power conferred upon the Central Government? 3. Whether the impugned notification, issued on the basis of the recommendations of an expert committee, can be found fault with on the ground that no opportunity was given to the manufacturers?
Ratio Decidendi: 1. The power exercised by the Central Government under Section 26A is primarily legislative in nature and hence, the principles of natural justice have no role to play. 2. The impugned notification, issued on the basis of the recommendations of an expert committee, cannot be found fault with on the ground that no opportunity was given to the manufacturers. 3. The decision taken by the Sub-committee comprising of 10 experts, on the basis of the material indicated in para 100 above, is sufficient to satisfy the precautionary principle and hence the impugned order of the Central Government cannot be interfered with.
Final Decision: The writ petitions were dismissed as devoid of merits.
Both the writ petitions challenge a notification issued by the Union of India, Ministry of Health and Family Welfare, imposing a ban on the manufacture, sale and distribution of a drug by name "Gatifloxacin".
2. I have heard Mr.G.Masilamani, learned Senior Counsel as well as Mr.R.Muthukumaraswamy, learned Senior Counsel appearing for the petitioners in both the writ petitions and Mr.G.K.R.Pandian, learned Central Government Standing Counsel for the respondents.
3. The Drugs Technical Advisory Board constituted by the Central Government in terms of Section 5(1) of the Drugs and Cosmetics Act, 1940, in its 58th Meeting held on 9.11.2009, took up for consideration, under Agenda item No.8, the proposal to reexamine continued marketing of 6 drug formulations, which were reported to be prohibited or restricted in certain countries. The drug formulations taken up for review are as follows:-
1. Nimesulide (analgesic)
2. Phenylpropanolamine (PPA) (decongestant)
3. Gatifloxacin (antibiotic)
4. Tegaserod (for irritable bowel syndrome in female)
5. Deanxit (FDC of Flupenthixol and melitracen) for psychogenic depression
6. Placenta Extract
4. The Drugs Technical Advisory Board (DTAB), hereinafter referred to as the 'Board', resolved in that meeting to constitute an Expert Committee comprising of seven members, for examining the issues relating to the safety aspects of the above 6 formulations. The Board also gave liberty to the Expert Committee to co-opt experts to facilitate review of the drugs, if required.
5. It appears that in respect of 3 drugs viz., Tegaserod, Gatifloxacin and FDC of Flupenthixol, the Sub Committee convened a meeting on 27.1.2011. The Committee appears to have met thereafter on 9.2.2011 and 17.2.2011, for considering the proposal, in so far as Gatifloxacin is concerned. In the meeting held on 17.2.2011, ten persons participated. One was the Professor and Head of the Department of Pharmacology, another was a Scientist from Indian Council for Medical Research, the third was the Honorary Secretary General of the Indian Medical Association, three were from CDSCO and four were special invitees.
6. It appears that one of the two representatives of All India Institute of Medical Sciences and the Director of Indian Veterinary Research Institute could not attend the meeting. Dr.R.R.Rai, Hony. Secretary General of the Indian Medical Association attended the meeting as representative of the said Association. One Dr.Anoop Misra of the Fortis Hospital, New Delhi, could not attend the meeting, but forwarded his recommendation on Gatifloxacin.
7. The Committee, as seen from its deliberations, took into consideration, the following facts:-
(i) that Gatifloxacin was approved by the Directorate on 3.10.2001 as a tablet and injection for the treatment of certain ailments;
(ii) that the drug is also approved as ophthalmic preparation;
(iii) that a study published in New England Journal of Medicine in March 2006 reported disturbances in blood glucose levels associated with the use of the drugs in patients of average 66 years of age;
(iv) that on 15.2.2006, M/s.Bristol Myers Squibb issued a letter to health care professionals, informing updation of warning and precautions in prescribing the drug;
(v) that the Office of the Drugs Controller General had the matter examined by the Monitoring Sub Committee of National Pharmaco-vigilance Advisory Committee (NPAC);
(vi) that the said Committee reported on 28.4.2006 that the incidence of disturbances in blood glucose levels with Gatifloxacin was very low;
(vii) that no specific reports of Dysglycemia were reported in India so far and there were no safety issues in general;
(viii) that the drug was withdrawn from the market in USA, Canada, Indonesia, Malaysia, Philippines, Singapore, Thailand, Brazil, Mexico etc., by the originator in 2006;
(ix) that the United States Food and Drug Administration Department removed Gatifloxacin from the list of approved drugs in 2008; and
(x) that in pu
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