Fixed dose combination drugs – to be banned or not to be banned

Ajay Bhargava, Vanita Bhargava and Aseem Chaturvedi, Khaitan and Co, explain how the FDC ban notification has adversely affected the pharma industry

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. There are boons and banes to every field and science certainly is no exception.

Earlier, the only medication that was given as a cure for fever, cold, cough etc. was 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 pharma companies developed combination drugs also known as Fixed Dose Combination Drugs (FDC). FDCs are combinations of two or more active pharma 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. for fever, the patient is usually administered 500 mg of paracetamol and for cold and 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, caffeine is added which is known 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 an 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, 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 available. 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 pharma companies were in for a shock when this notification was published.

Needless to say, the said notification adversely affected almost the entire pharma industry of the country; and had the notification gone unchallenged – it would have amounted to a loss of revenue of approximately Rs 3,000 Crores, annually.

The pharma 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.

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 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 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 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.

With much respite to the pharma companies, the Delhi High Court, vide its landmark judgment passed on 1 December, 2016 allowed all the writ petitions and quashed the notification dated 10 March, 2016, issued by the central government.

It will now be interesting to see how the central government reacts to the decision of the 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 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 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  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.

Whether the FDCs are a boon or deserve a ban, only time will tell.

Khaitan & Co, New Delhi acted for several of the affected pharma companies, namely, Glenmark Pharma, GlaxoSmithKline Pharma, Lupin , Wockhardt , Unichem Laboratories , Ajanta Pharma, Centaur Pharma, Blue Cross Laboratories, Tablet India, Unichem Laboratories, Yash Pharma , Serum Institute, FDC India, Coral Laboratories, Ruby organic & Labs, Akums Drug and Pharma, Koye Pharma, Hema Laboratories amongst others; and filed over 50 writ petitions.