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Dr. A.P. Vaitheeswaran v/s Director General of Health Services, Office of Drugs Controller General India (FDC Division), New Delhi & Others

    W.P. No. 29061 of 2019 & WMP. No. 28843 of 2019
    Decided On, 21 April 2022
    At, High Court of Judicature at Madras
    By, THE HONOURABLE DR. JUSTICE ANITA SUMANTH
    For the Petitioner: T. Balaji, S. Menaka, Advocates. For the Respondents: R1 to R3, Rajesh Vivekanandan Asst. Solicitor of India, R4, V.P. Chamuraj, Advocate, V. Usha, Additional Government Pleader, R5, No Appearance.


Judgment Text
(Prayer: Writ Petition filed under Article 226 of the Constitution of India, to issue aWrit of Certiorarified Mandamus, calling for the records of the fourth respondent relating to the proceeding in No.1627/DDC/AEON (Tamsulosin+Deflazacort)/U-II/2019 dated 12.09.2019 and quash the same and thereby revoke the cancellation of license and to withdraw the NOC reference letter.)

1. The petitioner is a company engaged in Innovation, Manufacture, Co-market and Export of Pharmaceuticals etc. An application had been made in terms of the Drugs and Cosmetics Rules to obtain approval for the manufacturing and marketing of Tamsulosin Hydrochloride 0.4 mg (as film coated modified release tablet) + Deflazacort 30 mg hard gelatin capsules.

2. Product permission was issued on 12.03.2012 and thereafter renewed for a period from 12.03.2017 to 11.03.2022. Based on the aforesaid approval, the petitioner has been manufacturing and distributing the product pan India.

3. While this is so, the petitioner was in receipt of the impugned communication dated 12.09.2019 from the Licensing Authority of the Department of Drugs Control bringing to the notice of the petitioner that the no-objection certificate initially issued by the Drugs Controller General (India) on 17.07.2015 for manufacture and marketing of the Tamsulosin Hydrochloride 0.4 mg (as film coated modified release tablet) + Deflazacort 30 mg hard gelatin capsules (product in question) was found 'infructuous'.

4. The permission accorded to the petitioner and licence for manufacture and distribution of the product was thus recalled/cancelled with immediate effect and the petitioner was directed to re-call the capsules from the market as well as surrender the original product permission for endorsement of the cancellation forthwith.

5. Mr.Rajesh Vivekanandan, learned counsel who is appearing on behalf of R1 to R3 would explain the impugned order in this fashion. The licence issued by the State Authorities for marketing and distribution of the product, is premised upon a no-objection granted by the Central Authorities, being R1 to R3.

6. It appears that the no-objection granted originally by the committee had been found to be erroneous since there had been an earlier rejection in regard to the same product by way of Government Order dated 09.10.2009. The aforesaid Government Order had not been taken note of by the committee that had granted approval on 12.03.2012. It is for this reason that, once the error was noticed, the authorities had proceeded to withdraw the no-objection granted and as a consequence thereof, the licence granted became unviable and liable to be cancelled.

7. However, the confusion does not stop there. A subsequent committee constituted by R1 to R3 has convened on 29.07.2020 to consider various Agenda including Agenda No.21, that reads as follows:

'AGENDA No.21

Consideration of the proposal to examine the prohibition of Fixed Dose Combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers and amendment in G.S.R. 738 (E) dated 09.10.2009

Board was apprised that, FDC of Tamsulosin HCI 0.4mg (as film coated modified release tablet)+Deflazacort 30 mg hard gelatin capsule was approved by Prof.Kokate Committee constituted by Ministry of Health and Family welfare vide order dated 16.09.2014 for examining the safety and efficacy of FDCs which were licensed by State Licencing Authority without prior approval of DCG(I).

However, Gazette notification G.S.R 738(E) dated 09.10.2009 under Section 26A of Drugs and Cosmetics Act, 1940 prohibits:-

'14. Fixed Dose Combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers'

Subsequently, there is a PIL in High Court, Patna in the matter.

The matter has been considered by the Ministry of Health and Family Welfare in consultation with DGHS as the product has been declared rational by the Prof.Kokate Committee, for deliberation of the matter for necessary amendment in the above notification accordingly in the DTAB.

In view of above, the entry No.14 of G.S.R. 738(E) dated 09.10.2009 to be amended and substituted by an entry and content as under:-

'14. Fixed Dose Combination of corticosteroid with any other drug [excluding FDC of Tamsulosin HCI 0.4mg (as film coated modified release tablet) + Deflazacort 30mg in hard gelatin capsule] for internal use except for preparations meant for meter dose inhalers and dry powder inhalers'

DTAB deliberated the proposal and recommended to exclude the FDC of Tamsulosin HCI 0.4 mg (as film coated modified release tablet) + Deflazacort 30mg hard gelatin capsule from the prohibition under vide GSR 738(E) dated 09.10.2009. Further, Board, in general, suggested that while granting permission to any new FDC, indication need to be specified.'

8. The proposal examined related to the prohibition of fixed dose combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry powder inhalers, and was a consequence of an order passed in a Public Interest Litigation filed before the Patna High Court.

9. Upon consideration of the issue, a resolution was passed substituting the earlier entry being:-

Fixed Dose Combination of corticosteroid with any other drug for internal use except for preparations meant for meter dose inhalers and dry power inhalers.

with

Fixed Dose Combination of corticosteroid

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with any other drug (excluding FDC of Tamsulosin HCI 0.4mg (as film coated modified release tablet) + Deflazacort 30 mg in hard gelatin capsule) for internal use except for preparations meant for meter dose inhalers and dry powder inhalers. 10. Thus, as on date, the stand of the petitioner is liable to be accepted and in fact, by virtue of the actions of the respondents, the impugned order is liable to be quashed and I did so. The effect has been given to the resolution by way of Notification dated 07.04.2021 in G.S.R.No.255(E). This writ petition is allowed. No costs. Connected miscellaneous petition is closed.
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