On March 10, 2016, the Central Drugs Standard Control Organisation, – or CDSCO, as it commonly known – issued a notification prohibiting the manufacture, sale and distribution of 344 Fixed Dose Combinations of drugs, popularly known as FDCs.
There have long been safety and efficacy concerns over FDCs in general and action against them had long been awaited. However, the manner in which CDSCO acted underlined serious problems with the working of the drug regulatory system in India. These include the unclear division of functions between Central and State licensing authorities and inadequate guidelines for taking action against violations.
These problems were exhaustively documented in a public interest petition filed against CDSCO by the Ranbaxy whistle blower, Dinesh Thakur, but dismissed by the Supreme Court only a day after the CDSCO notification.
But almost immediately, Pfizer dragged CDSCO to Delhi High Court, challenging the ban of one of the 344 FDCs, the popular cough syrup known as Corex.
No grave urgency?
The Delhi High Court granted an interim stay on the ban until March 21 to Pfizer, a similar injunction against the ban on Phensedyl (another cough syrup) and Vicks Action 500. The interim stay has been granted on the grounds that the drug has been marketed for 25 years and that the notification banning it does not disclose any “grave urgency”. The court’s order also records the alleged objection of the manufacturers that they had been denied a hearing before the ban was imposed.
Large sales volumes of FDCs in India, in comparison to Britain and United States of America, have been deliberated upon by expert committees since the 1980s and bans on various combinations have periodically been issued.
In 2015, a study of FDCs in four therapeutic areas demonstrated that there were multiple formulations available on the Indian market that had been banned, restricted or never approved internationally. Ideally, then, CDSCO ought to be able to make out a strong case upholding its ban. Case law on similar bans would appear to bear this out.
The Central government imposes such bans by exercising its powers under Section 26A of the Drugs and Cosmetics Act, 1940. This provision allows the government to prohibit the manufacture, sale or distribution of drugs that are likely to pose a risk to human beings or animals, or that do not have the therapeutic value that they claim, or contain ingredients in quantities for which there is no therapeutic justification. The Central government must also be satisfied that it is necessary or expedient in the public interest to impose such prohibition.
There is no mention in the provision of the “grave urgency” that the Delhi High Court order mentioned while granting an interim stay on the ban. In any case, in previous instances involving Section 26-A bans, courts have been unsympathetic to the argument that the drugs in question have been available on the market for several years and therefore, there is no danger to public health.
This is because Section 26-A does not restrict the government’s power to life threatening situations. Bans may be imposed even when there is no therapeutic justification for the drug in question, even though the drug might not pose a risk to human health. In any case, courts have stayed away from reviewing the technical merits of bans, restricting their enquiry to whether the regulator had sufficient material on which to base its decision.
The contention of the manufacturers that they were entitled to a hearing before the ban was imposed has no basis in Section 26-A either. Courts have held that the Drugs and Cosmetics Act constitutes a complete code in itself and that principles of natural justice have no role to play in the exercise of a power that is primarily legislative in nature, like the power under Section 26-A.
What this means is that the manufacturers affected in this case might not be able to argue for the lifting of the ban solely on the ground that they were not offered the opportunity to make a representation. Even the fact that other manufacturers, unlike them, might have been given such an opportunity, is not sufficient to create an entitlement to a hearing.
The real issue
Although there might be enough technical material and legal precedent to support CDSCO’s orders, it is very worrying that a situation such as this was allowed to arise, that is 344 drugs without any therapeutic justification were allowed to enter the market. Apart from concerns about safety and efficacy, many FDCs were also allowed to enter the market illegally. State Drug Authorities issued manufacturing licences for such FDCs without obtaining Central approval from CDSCO. This contravenes Rules 122B (3) and 122D, read with Rule 122E of the Drugs and Cosmetics Rules, 1945.
These provisions explicitly include FDCs within the definition of a “new drug”. When applying for approval to a State licensing authority to manufacture a new drug, the applicant must also provide evidence that the Central licensing authority, CDSCO, has approved the drug.
These regulatory violations first came to the notice of CDSCO in early 2013, when it issued directions to State Drug Authorities to ask the manufacturers of such unapproved FDCs to demonstrate their safety and efficacy, failing which the drugs would be considered for prohibition. When very few manufacturers submitted such evidence to CDSCO, it directed them to make an application in Form 44 which would be considered in consultation with an expert committee.
Form 44 is used by applicants seeking permission to import or manufacture a new drug. Through its March 10 notification, what CDSCO has done in effect is to refuse approval for the manufacture of new combinations, rather than prohibit the manufacture of drugs that were legally on the market. However, the use of Section 26-A to ban these drugs ignores this important legal distinction.
CDSCO and State Drug Authorities were caught sleeping on the job. The government must recognise that the weakness of the legal and regulatory framework contributed to this. One of the prayers in Dinesh Thakur’s petition asked for a reference to the Law Commission of India to consider the need for a new law on pharmaceutical regulation. Despite the dismissal of the petition by the Supreme Court, the government ought to initiate this process of its own accord.
Dhvani Mehta heads the Public Health and Environmental Justice Initiative at the Vidhi Centre for Legal Policy, New Delhi.