This article is written by Vividh Jain, a student of the Institute of Law, NIRMA University. In this article, the author presents a suggestive critical analysis of the Supreme Court judgement in the case of Union of India and ANR. vs. Pfizer Limited and Ors. and also recommends some suggestions which make this judgement more suitable. 

Introduction

In the Delhi High Court, the petitioners, Pfizer Limited and ors. had filed a petition, inter alia, praying for a ban or prohibition on the importation, manufacture, distribution, exportation and sale of the fraudulent drugs manufactured by the Respondent number 3 (Lucius Pharmaceuticals including Lucisun, Lucipalb, Lucicriz, and Lucia) The petitioners (Pfizer Limited and Ors.) are the production company that manufactures certain kinds of drugs that are used for the treatment of a deadly disease named cancer. The petitioners, Pfizer Limited and ors. alleged that the fraudulent drugs manufactured by the Respondent number 3 (Lucius Pharmaceuticals) are being sold and marketed in India without the requisite and proper license issued by the Drug Controller. It was also alleged that Respondent number 3 is a fictitious company and it has no traceable address in Sri Lanka and is selling and manufacturing infringed life-saving drugs. The products produced by Respondent number 3 are unlicensed, spurious and misbranded and claim to treat dangerous life taking disease like cancer. 

Various observation by Delhi High Court

The petitioner filed a petition in Delhi High Court in the case of Pfizer Limited and Anr. vs. Union of India and ors. praying for a ban or prohibition on the importation, manufacture, distribution, exportation, and sale of the fraudulent drugs manufactured by the Respondent number 3, Lucius Pharmaceuticals including Lucisun, Lucipalb, Lucicriz, and Lucia. In this writ petition against the Government of India and an entity Lucius Pharmaceuticals, the Hon’ble Delhi High Court observed the following: 

1. The Government of India and the Drugs Controller’s Office i.e. Respondents number 1 and 2 respectively, confirmed that the drugs manufactured by Respondent number 3, Lucius Pharmaceuticals (Lucipalb – Palbociclib, Lucicriz – Crizotinib, Luciax – Axitinib and Lucisun – Sunitinib) are specious, fraudulent and no permission and license for sale and distribution has been granted by the Central Drugs Standards Control Organization (CDSCO) for the said drugs. 
2. In this regard, the Government of India contended that the preventive measures to control the sale of these specious drugs are required to be taken by the State Government and if the petitioners, Pfizer Limited and ors. provide the information regarding the sale of this drug or where the drugs are being sold, the Central Drugs Standards Control Organization (CDSCO) should coordinate with the concerned State Government to take an appropriate action. 

Delhi High Court verdict

The Hon’ble High Court of Delhi held that the import and sale of the drugs manufactured by the Respondent number 3, Lucius Pharmaceuticals including Lucisun, Lucipalb, Lucicriz, and Luciax are illegal. The Court has also asked the petitioners, Pfizer Limited and ors. to provide the crucial information regarding the sale of this drug like where the drugs are being sold to the Respondent number 1 and 2. Also, directed the petitioners to file the complaints in this regard before the State authorities. 

The Hon’ble High Court further directed the Government of India (Respondent number 1) to take necessary steps and legal action against Respondent number 3 in coordination with the Central Drugs Standards Control Organization (CDSCO) and the concerned State Government. The Court also issued certain directions and guidelines to the effect that if any complaint or allegations are made concerning the drugs in question, the respective State authorities shall take reasonable action in compliance with the law to prohibit the selling of the fraudulent, specious and unlicensed drugs and to prosecute the offenders as soon as possible to the fullest extent of the law.

Hence, the Hon’ble High Court of Delhi held these drugs manufactured by the Respondent number 3, Lucius Pharmaceuticals including Lucisun, Lucipalb, Lucicriz, and Luciax are specious and its import and sale in the territory of India are illegal.

Appeal to the Supreme Court of India

Lucius Pharmaceuticals including Lucisun, Lucipalb, Lucicriz, and Luciax challenged the Delhi High Court verdict in the Supreme Court of India in the case of Union of India and ors. vs. Pfizer Limited and Anr. In December 2017, the Supreme Court of India delivered its verdict on the ban imposed by the Government of India on the marketing of 344 FDCs or Fixed-Dose Combinations which is the type of medicine made up of cocktails of two or more ingredients/drugs. Since the late seventies, these Fixed-Dose Combinations have been marketed by the Indian pharmaceutical industry as a way of circumventing the government’s price control orders. Many of these Fixed-Dose Combinations have been licensed by the State Licensing Authority which violated the existing Drugs and Cosmetic Act, 1940. These Fixed-Dose Combinations were lacking in any scientific and clinical basis to determine their efficacy and protection for therapeutic benefit.

The government’s decision to prohibit or ban the marketing of these unreasonable drugs was based on the recommendations of a special committee headed by Professor Chandrakant Kokate and also was made as per Section 26A of the Drugs and Cosmetics Act, 1940. Since there were thousands of Fixed Dose Combinations present in the pharmaceutical market, the ban imposed by the government hit the profit of the entire pharmaceutical industry. As the pharmaceutical industry suffered a lot of degradation in the profit, they challenged the ban imposed by the government on these Fixed-Dose Combinations on the grounds that the Central government had not consulted the matter with the DTAB or Drugs Technical Advisory Board, which is a statutory body set up under Section 5 of the Drugs and Cosmetics Act, 1940. 

The petition had been filed before the Delhi High Court challenging the ban imposed by the government on these Fixed-Dose combinations. Justice Endlaw set aside the orders banning these Fixed-Dose Combinations on the ground that the government had not consulted the matter with the Drugs Technical Advisory Board and the petition succeeded. This verdict of Delhi High Court was challenged by the Central government and an appeal was made to the Supreme Court of India. The Supreme Court overruled the Delhi High Court’s judgement by stating that Section 26A of the Drugs and Cosmetics Act, 1940 does not require the Central government to consult the matter with the Drugs Technical Advisory Board. 

The flaws which need to be recalled

The Supreme Court after making such an assertive judgement on why Section 26A of the Drugs and Cosmetics Act, 1940 does not require the consultation with the Drugs Technical Advisory Board, the Supreme Court just relied on the contentions made by the government counsel and ordered the Central government to refer this matter to the Drugs Technical Advisory Board, which was exactly opposite to the legislation enacted by the parliament. In this judgement, the apex court stated that the case of 344 Fixed-Dose Combinations should be consulted with the Drugs Technical Advisory Board so that the advisory body can examine each aspect of these cases and ultimately send the final report to the Central government. It is unbelievable that the public prosecutor made such a recommendation to the Supreme Court to practically ignore the law or legislation enacted by the parliament and shocking that the Supreme Court approved these recommendations which contradict its own judgment. Section 26A empowers the central government to impose ban or prohibition on drugs but now, the apex court itself ignored the law and procedure established by the legislative authority. 

The Supreme Court of India’s direction to the Drugs Technical Advisory Board to constitute a hearing for all these pharmaceutical companies who have currently indulged in selling these irrational Fixed-Dose Combinations and to prepare a comprehensive report before making recommendations to the Central government makes the matter worse. This direction directly contradicts the assertion made by the Apex Court earlier in its judgement where it said that Section 26A of the Drugs and Cosmetics Act, 1940 does not require the Central government to consult the matter with the Drugs Technical Advisory Board and refused to entertain a question as to whether the power under Section 26A of the Drugs and Cosmetics Act, 1940 is legislative or quasi-judicial in nature. Furthermore, the apex court laid down that the power under Section 26A of the Drugs and Cosmetics Act, 1940 is legislative in nature and thus excludes natural justice. 

If instead, the Supreme Court had addressed this particular issue, it would have realized that the power mentioned under Section 26A of the Drugs and Cosmetics Act, 1940 is legislative in nature, which means that the government is not required to hear the parties affected by such law or legislation. Legislative power is an equivalent of making legislation and it is no one’s case that before making any law, the government must compulsorily hear everybody who has been affected by such legislation. The apex court by forcing the Drugs Technical Advisory Board to conduct hearing in this matter and by implicating the principles of natural justice empowers the pharmaceutical companies who are dealing with the irritation drugs to waste the crucial time of the court and the Drugs Technical Advisory Board and now these pharmaceutical companies would try to spend the crucial working hours on making arguments on why they need to sell these Fixed-Dose Combinations and use every opportunity to drag the Drugs Technical Advisory Board to the court for not following the proper procedure. 

Misinterpretation of the CK Kokate committee

One of the most sizzling problems with this judgment of the Supreme Court is its virtual annulment of the extensive report presented by the Chandrakant Kokate Committee. The apex court after seeking the Kokate committee report concluded that the Kokate Committee only suggested the ban on those Fixed-Dose Combinations without giving the proper reason behind such suggestion. This conclusion is wrong in the eyes of law as it was never the duty of the CK Kokate Committee to make a policy decision under Section 26A of the Drugs and Cosmetics Act, 1940. In other words, the central government had never assigned the power under Section 26A of the Drugs and Cosmetics Act, 1940 to the CK Kokate Committee. The committee’s sole job was to examine the drugs and give a scientific opinion on their therapeutic benefit. The Kokate Committee made a factual statement in its study that these Fixed-Dose Combinations are irrational and were lacking in any scientific and clinical basis to determine their efficacy and protection for therapeutic benefit. It was then the Central government’s duty to make the policy determination based on recommendations made by the Kokate Committee, as to whether these drugs had to be banned on the grounds under Section 26A of the Drugs and Combination Act, 1940.

This policy of banning those Fixed-Dose Combinations was made by the Central Government with the recommendation of the Ministry of Health and Family Welfare. In the order, it was clearly mentioned that the Fixed-Dose Combinations pose threats to human life and it’s safer substitutes are easily available in the market. Astonishingly, these orders are not discussed in detail in this judgement. The Supreme Court makes another error in this judgement when it directs the Drugs Technical Advisory Board to determine according to Section 26A of the Drugs and Cosmetics Act 1940, but did not entertain the recommendations made by the Chandrakant Kokate Committee in regards to banning the marketing of these Fixed-Dose Combinations. By doing so, the Apex Court ignored the fundamental fact that Section 26A of the Drugs and Cosmetics Act, 1940 empowers only the Health Ministry and not the bureaucrats of the Drugs Technical Advisory Board. 

Conclusion

The Supreme Court’s judgement in the case of the Union of India and ors. vs. Pfizer Limited and Anr. is quite commendable as it overruled the Delhi High Court’s judgement by stating that Section 26A of the Drugs and Cosmetics Act, 1940 does not require the Central government to consult the matter with the Drugs Technical Advisory Board. This judgement shows the power of the Supreme Court to go beyond the law and legislation and deliver the judgement which the Supreme Court thinks is suitable for the benefit and welfare of the society at large. Also, this judgement shows that the Judiciary is above the Legislation if we talk about the implementation of laws. Hence, it is concluded that this judgement is not far from the flaws and needs to be recalled because, in its present form, it sends a warning to all the concerned High Courts that judges can easily sidestep the legislative process on a complex regulatory matter if such process is inconvenient.

References 

• https://www.lexology.com/library/detail.aspx?g=d69b9657-f6d5-45f4-aa08-54b92e75026a
• https://scroll.in/pulse/863078/why-the-indian-supreme-courts-judgment-on-combination-drugs-sends-wrong-signals

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