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Delhi High Court Junks FDC Ban Imposed by the Central Government for Failure to Follow Due Process

By: Ramesh Vaidyanathan and Mahafrin Sidhwa

The Delhi High Court (HC) has given a major respite to pharmaceutical companies in the case of Pfizer Limited & Anr V. Union of India & Anr by quashing 344 Notifications dated 10th March 2016 issued by the Central Government seeking to prohibit 344 Fixed Dose Combinations (FDC) from being manufactured and distributed in the territory of India. FDCs form a major part of medical compositions used in curing cough reflexes, bronchial, respiratory and dermatological disorders.

The Central Government had issued these notifications  prohibiting  FDCs from being manufactured and distributed in India. This significantly affected pharmaceutical companies such as Pfizer,  Abbott, Macleods Pharma, Glenmark, P&G  and Cipla who  were manufacturing and selling FDCs  under valid licenses issued by the State Licensing Authority (SLA).

Pfizer filed a petition in the Delhi High Court along with 453 others  challenging  the 344 notifications issued by the Central Government. In Pfizer’s case,  it was prohibited from manufacturing, selling and distributing its well known cough syrup Corex  based on one such notification as it contained Chlopherniramine Maleate and Codeine Syrup. The notification claimed that the FDC was “likely to cause risk to human beings” and that “safer alternatives were available”.

Pfizer’s main contention was that Corex was operating under a valid license issued by the SLA and the Drug Controller. The cough syrup drug contained Chloropheniramine Maleate and codein phosphate, which were necessary and without which the drug was meaningless. While the  notification claimed that “safer alternatives were available”, it failed to disclose any such  alternatives.

It was further contended that the notification did not  prove any evidence of human beings at risk by the consumption of the cough syrup, which was being used since 1989. Also, the Drug and Cosmetics Act 1940 (Drugs Act) and the Drugs and Cosmetics Rules 1945 (Drug Rules)  required the Central Government to exercise its powers under Section 26A of the Drug Act based on advice  from the Drug Technical Advisory Board (DTAB), Drugs Consultative Committee (DCC) and the Central Drug Laboratory, under Sections 5, 6 and 7 of the Drugs Act. This process was not followed before issuing the impugned notifications.

On the other hand, the Central Government contended that Corex was not mentioned as an approved drug in the list of FDCs approved by the Ministry of Health and Family Welfare, Government of India (Ministry), which was published on the website of Central Drugs Standard Control Organisation (CDSCO) in the year 2013. Secondly, it was contended that the Drugs Controller was the competent licensing authority and that existing licenses issued by the State Licensing Authority (SLA) were not valid.

It was further contended that Corex should be regarded as a “new drug” as the composition had changed since its last approval from the Drug Controller in the year 1995 and the approval back then was based on the literature and knowledge available at that point of time. This does not bar reexamining the FDC in the current scenario in the light of the latest scientific knowledge even if it was being manufactured from  1989. The Central Government further contended that the cough syrup drug had adverse effects such as sedation and drowsiness and also would interfere with the reflexes of children and geriatric patients. Lastly, it was contended that DTAB was not involved in the grant of approval to any drug and thus could not have any compulsory role in the prohibition of any drug as was contended by Pfizer. The Central Government exercised its powers under Section 26A in its legislative capacity and there was no mandate for the Central Government to take advice from DTAB and the Court should not interfere with the satisfaction reached by the authority vested with the exercise of power.

Justice Rajiv Sahai Endlaw was faced with two main issues. Firstly, whether the Central Government was entitled to exercise its power under Section 26A of the Drugs Act without consulting or even involving the DTAB and the DCC?  The second question was whether the Central Government was empowered to exercise this power in consultation with and on the advice of another authority of technical persons, i.e., CDSCO, an organisation constituted by the Central Government.

The Judge was of the opinion that if the Central Government was not empowered to declare a drug as a patent or proprietary medicine without consultation with DTAB, the Central Government was also not empowered to declare a drug as risky or not having therapeutic value without consultation with the DTAB. The necessity for the Central Government to dispense with such consultation was provided only under Section 33 of the Drugs Act provided there was some exigency for the same. Also, even when consultation was not sought by the Central Government, the said Section provides for post facto consultation within 6 months of making such a decision.

The Judge was of the opinion that the Central Government had acted beyond the scope of its power by issuing 344 notifications without consultation with the DTAB and DCC and ruled  that the notification was passed without following prescribed procedure and should be held null and void ab initio. The judgment affirms the maxim that ‘what is prescribed to be done in a particular way must be done in that way and no other way’.

The Judge also held that CDSCO was not a statutory authority under the Drugs Act and hence was not empowered by the Drugs Act to discharge functions assigned by the Central Government. Accordingly, all 344 notifications were set aside.  

In our view, this judgment will be a morale booster to the pharmaceutical industry that has  been attempting cures for various respiratory disorders that have stood the test of time. At the same time, the Central Government does need to address the concern of public health by passing important notifications after the “due process” as mandated under the statute. The Central Government passed all 344 notifications in a haphazard manner without application of mind, without establishing the purported hazards to human beings on consumption of these drugs and also without providing a list of safer alternatives in the notifications. Since the Central Government still may have serious concerns on  the FDCs, it would be best to review existing licenses as per the regime under the Drugs Act and the Drug Rules and only after adequate research and consultation with the DTAB and DCC pass notifications on FDCs, keeping in mind the therapeutic usage of drugs, the number of years it has been used and the number of complaints received from the general public that prove the “risk to human beings in India”.


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