Fixed Dose Combination Drugs - To Be Banned Or Not To Be Banned

Ajay Bhargava

Vanita Bhargava

Aseem Chaturvedi
Principal Associate

Arvind Kumar Ray
Senior Associate

A Fixed Dose Combination (FDC) is a cocktail of two or more active drug ingredients in a fixed ratio of doses. To prevent rampant over-prescription and harmful side-effects the Govt banned these drugs on the recommendations of an expert committee headed by Chandrakant Kokate. This article will discuss mechanism of the action, pros and cons.

The human body, is a complex structure. The human body is also prone to various ailments and the billion-dollar Pharmaceutical Industry comes to the rescue, with drugs and treatment options for us, to enjoy a happy and healthy life.

With the advancement of science and technology, the Pharmaceutical Industry has also grown and evolved. Various ailments, which could not be treated before, are easily diagnosed and medication is available for its treatment. However, with the advancement of science, comes its drawbacks.

Back in the days, the only medication that was given as a cure for fever, cold, cough etc. was a tablet of a salt known as Paracetamol. Paracetamol, till date, is considered a safe option for treating fever and flu. However, with the advancement of science, various other medicines were developed for combating cold, flu, fever etc. The Pharmaceutical Companies, also developed combination drugs, also known as Fixed Dose Combination Drugs (FDC). FDCs are combinations of two or more active pharmaceutical ingredients in fixed ratios, given in the form of a single dose.

For example, a patient suffering from fever, cold, cough etc. would ideally have to take 3 medicines i.e. one to treat fever, the other for cold and the third for cough. The Pharmaceutical Companies, developed a FDC, which have salts to treat all three ailments in one tablet and the patient can be cured by intake of 1 tablet only. For fever, the patient is usually administered 500 mg of Paracetamol. For cold & cough the patient is usually administered 10 mg of Phenylephrine Hydrochloride.

However, Phenylephrine Hydrochloride is known to cause drowsiness. In order to get rid of the side-effect of drowsiness, the Pharmaceutical Companies added caffeine, known for centuries to keep people awake.

Thus, when the Companies added 500 mg of Paracetamol + 10 mg of Phenylephrine Hydrochloride + 32 mg of Anhydrous Caffeine, they formulated a FDC to treat common cold, cough, throat pain and fever, which in the common market is known and available as D-Cold Total. Similar combinations are available in the market under different trade names such as Ascoril-D, Wickoryl etc. manufactured by different companies. Some other popular examples of FDCs are Pfizer's Corex, Piramal Healthcare's Saridon, Merck India's Nasivion, Glenmark's Ascoril and Candibiotic, Lupin's Gluconorm etc .

The Government of India, however, sought to ban this mushroom growth of FDCs . Exercising its powers under Section 26A of the Drugs & Cosmetics Act, 1940 (the Act), the Central Government, through its Department of Health & Family Welfare; issued a Notification dated 10 March 2016(please see the appendix), whereby 344 Fixed Dose Combination (FDC) Drugs were banned with immediate effect. The Notification purported to ban the FDCs for the reason that they involved risk to human beings and that safer alternatives to the same were avaiable.

Further, the Notification was also purported to be based on the findings and recommendations of an Expert Committee appointed by the Central Government, which stated that the FDCs in question were found to have no 'therapeutic justification'. Lastly, the Notification was, of course, touted as an exercise in 'public interest'. Hundreds of Pharmaceutical Companies were in for a rude shock when this Notification was published.

Needless to say, the said Notification adversely affected almost the entire Pharmaceutical Industry of the country; and had the Notification gone unchallenged - it would have amounted to a loss of revenue of approximately 3,000 Crores, annually.

The Pharmaceutical Industry immediately proceeded to challenge the Notification on various grounds. Although, several Writ Petitions were filed before various High Courts of the country - the Delhi High Court, having passed the first interim Order dated 14 March 2016 concerning the Notification in WP (C) No.2212 of 2016, directing that no coercive action will be taken by the Government in furtherance of the Notification, till further orders - became the hot-bed of the present litigation.

However, the Division Bench of Madras High Court in its Order dated 22 March 2016 in W. P. No. 10536 of 2016 titled as "Federation of South Indian Pharmaceutical Manufacturers Association vs Union of India" and W. P. No. 10538 of 2016 titled as "Commonwealth Pharmaceuticals vs Union of India", disagreed with the interim Order passed by the Delhi High Court and refused to grant stay on the Notifications.

Soon, various other companies followed and flooded the Court room with Petitions challenging the ban; and a total of 455 Writ Petitions were filed before the Delhi High Court. To maintain decorum in such a circumstance the Hon'ble High Court, in an unprecedented measure, directed that only 1 lawyer per matter be allowed to enter the Court room. The Petitions were heard by Hon'ble Mr Justice Rajiv Sahai Endlaw, over a period of nearly three months, with several days of back to back hearings

The companies challenged the ban on, inter-alia, the following grounds:
  • Violation of Article 14 of the Constitution of India, in as much as the Notification was issued in an arbitrary manner; in violation of the principles of natural justice; was unreasonable, harsh and unscientific.
  • Violation of Article 19(1)g, in as much as the Notification was an unreasonable restriction upon the business and trade of the Petitioners.
  • Violation of the procedure prescribed under the Act, for exercise of powers under Section 26A, in as much as the Notification was issued without the mandatory consultation with the Drugs Technical Advisory Board(DTAB) and the Drugs Consultative Committee (DCC), as constituted by virtue of Sections 5 and 7 of the Act, respectively.
  • The primary ground of challenge in most of the Petitions was that there was a violation of the principles of natural justice, more particularly the principle of audi alteram partem - in as much as no Show-Cause Notice was issued to the Petitioners, enabling them to empirically justify their production/sale of the banned FDCs. It may be noted that a Show-Cause Notice was, in fact, duly issued to some of the Petitioners; and the said Petitioners, nonetheless, went on to challenge the Notification, inter-alia, on the ground that no personal hearing was afforded to them.
  • It was also stated that most of the affected drugs had been in production for several years (decades, in some cases); and had been successful in treating lakhs of patients across the country. Accordingly , it was submitted that the ban was unwarranted and the imposition of the same with immediate effect, was all the more arbitrary and unreasonable.
  • More importantly, the Hon'ble Court was apprised of the fact that the FDCs in question, in most of the Petitions, had been under production, on the basis of the requisite Licenses and approvals issued by the Drugs Controller General of India DCG (I) ITSELF and/ or the relevant State Authorities. In this regard, it was submitted that the said Licenses and approvals were given only after examining the efficacy and suitability of the relevant drug; and that it was astonishing that the Government, would now, all of a sudden, brand the same drugs as unsafe.
Apart from the above, certain other grounds of challenge included perverse constitution of the Expert Committee; unscientific methods adopted to reach the conclusion that the FDCs in question did not have any therapeutic justification etc. The Judgment was reserved on 2 June, 2016.

Per contra, the Central Government justified the ban on FDCs on various grounds. However, the key argument of the Central Government was that the Notifications had been issued by the Central Government in exercise of its powers under section 26A of the Act. The power under Section 26A is in the nature of legislative power. A legislative action is not subject to the compliance with principles of natural justice and there is no requirement of issuance of show cause or hearing for the exercise of power under Section 26A. Further, consultation with the DTAB /DCC is not a mandatory requirement for the exercise of power under Section 26A.

With much respite to the Pharmaceutical Companies, the Delhi High Court, vide its landmark Judgment passed on 1 December, 2016 (which runs into 113 pages) allowed all the Writ Petitions and quashed the Notification dated 10 March, 2016, issued by the Central Government. The Delhi High Court ruled that the Act requires the Central Government to exercise the power under Section 26A after taking advice from and in consultation with the statutory bodies i.e., the DTAB and DCC. The exercise of power without such advice and consultation cannot be sustained even if exercised bona fide and in consultation with and on advice of other experts who may be as competent as the DTAB and DCC. The power of regulation, restriction or prohibition under Section 26A cannot be exercised in public interest, for any reason other than the drug posing a risk to consumers thereof or having no therapeutic value or no therapeutic justification.

It will now be interesting to see how the Central Government reacts to the decision of the Hon'ble Delhi High Court. The following three possibilities, in no order of likelihood, seem to be in the offing:
  • The Central Government may accept the decision and give up the entire exercise concerning FDCs, altogether.
  • It may accept the decision, but, go on to undertake the entire exercise, afresh - removing the infirmities, as pointed out by the Hon'ble Delhi High Court.
  • It may challenge the decision and file an appeal against the same.
The proceedings also assume importance as the impugned action of the Central Government was purportedly undertaken to further public interest and to protect public health, in particular. In such circumstances, the Hon'ble Court was faced with a fairly vexed issue and was called upon to circumscribe the powers of the Central Government, within the contours of the procedure prescribed under the specific law and the settled principles of common law. To that end, the Hon'ble Court made it clear that an exercise affecting substantive rights, if undertaken in violation of the law, would not be permitted to prevail - notwithstanding the fact that it is seemingly peddled to be in furtherance of public interest.

It is also interesting to note that after the judgment was reserved by the Delhi High Court, the Central Government filed a Transfer Petition [T. P. (C ) No. 1729-1737 of 2016] seeking transfer of various petition pending before various High Court, wherein the Notifications have been challenged, to the Supreme Court. The said Transfer Petition is presently pending before the Supreme Court. It would be interesting to see the stand of the Central Government in the Transfer petition considering the judgment of the Delhi High Court whereby all 344 Notifications have been struck down.

Whether the FDCs are a boon or deserve a ban, only time will tell. While a certain section of the public have criticised the judgment of Delhi High Court, the pharmaceutical companies are preparing themselves for another battle in case the Central Government initiates fresh action against the FDCs in accordance with the law.