The High Court is expected to rule next week on a challenge by Dr. Balwant Singh’s Hospital to a decision by Public Health Minister Volda Lawrence that it says is preventing it from importing pharmaceuticals from India.
In an application, the hospital’s Chief Executive Officer (CEO) Dr Madhu Singh contends that Minister Lawrence has refused to accept registration certificates for the pharmaceutics that it has supplied in accordance with the Food and Drugs Act.
Deputy Solicitor-General Deborah Kumar who represents the minister, is, however, arguing that the certificates were not accepted because they were not deemed “sufficient.”
At a hearing for arguments at the High Court in Georgetown yesterday afternoon, Justice Fidela Corbin-Lincoln took Kumar to task to highlight the reasons for the minister’s rejection of the certificates.
The judge pointed out that while in accordance with the Act the minister has a wide discretion in accepting and/or rejecting the certificates, the exercise of that discretion could not be done in a capricious manner. Against this background, the judge highlighted the need for reasons to be provided by the minister for refusing to accept the certificates for the drug.
The judge pointed out that in accordance with Section 78 (2)(k)(v) of the Act, which deals with Food and Drugs Regulations, the applicant had done what was required in so far as providing the necessary registration certificates for the drugs.
Examining the minister’s missive rejecting the certification, Justice Corbin-Lincoln said that what the minister seemed to have done, in contravention of the Act, was to herself assess the safety of the drugs.
This, the court noted, was not a function for Minister Lawrence, but rather it was her task to assess by whom the certificates had been issued and their contents in making a determination as to whether or not she would accept or reject.
Having failed to so do, the judge said, the question arises as to the criteria employed by the minister for rejecting the certificates.
With hearings having been completed in the matter, the court noted that it will deliver its ruling next week at a date to be fixed.
The hospital is being represented by attorney Devindra Kissoon.
Routinely
In her affidavit, Singh said that her hospital routinely uses lifesaving and pain reducing pharmaceuticals, such as antibiotics, cardiac drugs and medicines, necessary during surgery and for treatment of patients in its operations, and often on an emergency basis.
She said since these drugs are often unavailable for purchase locally, they necessitate importation.
Referencing Section 78(2)(k) of the Act, Singh noted that it requires an applicant to provide one or more certificates which verify the integrity of the new drugs’ manufacturing process. These include certificates from Canada, the United States, the United Kingdom or Australia. Subsection v of the Act affords for a proviso. It states, “[or] a certificate in the English language respecting the safety of the new drug for conditions of use recommended and giving the conditions under which it may be sold, issued by an official body or government department having authority to issue such certificate, such official body or government department having the experience and facilities for testing the safety of new drugs that are considered by the minister as adequate to ensure the safety of the new drug under the conditions of use recommended.”
Singh advanced that once that certificate is authentic, the minister is not permitted to look beyond the certificate.
She said that since none of the drugs imported by her hospital originate from Canada, the United States, the United Kingdom or Australia, she has routinely satisfied the requirement of Section 78(2)(k) by submitting the documentation required by 78(2)(k)(v) and has always been issued licences by the Food and Drug Department (FDD).
Singh said that her hospital has been so doing since at least 2004.
According to her affidavit, they have routinely applied to the director of the FDD for licences to import and sell pharmaceuticals pursuant to Section 78 of the current Food and Drug Regulations, and since that date the director and/or the minister (or the FDD with the sanction of the minister) has routinely issued the hospital with the necessary licences or corresponding waivers as the case may be.
By various applications, dated December 29th, 2016, February 10th, 2017 and March 6th, 2017, Singh said the hospital had applied to the government for a licence to import and sell 17 different types of injections.
According to Singh, not only at all times were drugs applied for sourced from highly reputable large-scale manufacturers, but they have always measured up to safety requirements and she noted that certification was issued only after documentation was produced about bio availability, bio equivalence and stability.
Singh said it was important to note that her hospital was simply applying for registration of drugs, which has already been developed and approved in other countries. Clinical trials of the drugs, she said, had also already been completed and approved in the development stage, which she added may take up to 12 to 15 years for development. She said her hospital is not trying to register experimental drugs or any drug which has not been approved for human use. On this point, she said that they are instead concerned with drugs which have been manufactured by two of India’s largest and well established pharmaceutical companies—Bharat Serums & Vaccines Ltd and VHB Medisciences Limited—and Merck Serono-a multinational company established in 1668.
Singh said that her hospital’s applications fully satisfy the requirements of Section 78 of the Food and Drug Regulations, and in particular, Section 78(2), while emphasising that all necessary documentation had been supplied to the minister.
She noted further that her applications contain the identical information as applications made and which were granted by the government in 2015 and 2016.
‘Jeopardising patients’
The doctor complained that despite multiple requests to the FDD and minister to grant the applications, she has arbitrarily and capriciously refused and/or delayed to do so, threatening the treatment, life, safety and wellbeing of patients as well as the hospital’s operations as a whole.
Singh said that after making many inquiries as to the status of her applications in May of 2017, she was informally informed by various importers of drugs that the government had indicated in the press that that it had implemented new policies concerning the implementation of the regulations governing the issuance of licences for the import and resale of drugs, and in particular, a blanket policy restricting the importation of India-manufactured drugs.
As a result, she said she wrote to Director of the Government Analyst-Food and Drug Department, Marlan Cole, requesting information concerning the new requirements of registration but received no response initially.
Sometime later, however, she said, owing to multiple requests, a meeting was convened to discuss the status of the applications at which the FDD and the minister had implemented a new policy concerning the issuance of licences to import or resell drugs, whereby only documentation that satisfied the requirements of Section 78(k)(i) – (iv) of the regulations would be accepted, and that applications that contained the documentation required under Section 78(k)(v) would be rejected.
She said it was expressly stated at that meeting that only drugs registered in the United States, Canada, Australia or the United Kingdom would be issued licences. Singh said it was also made clear to her at the meeting that drugs for which her hospital had already been granted an import licence would be reviewed and the aforementioned policy would be applied to existing registrations, effectively meaning that drugs previously licensed despite satisfying the requirements of Section 78(2)(k)(v) of the regulations would be deregistered.
The hospital’s CEO is arguing that the policy effectively results in an illegal prohibition of importation of drugs manufactured in India or elsewhere without just cause. She said that while at that meeting she was informed that there were new policy guidelines concerning the requirements to issue licences to import and resell new drugs, state agents refused to provide her with those guidelines despite her demands.
Singh is seeking, among other things, an order of certiorari quashing the FDD’s decision to refuse to issue and/or to recommend to the Minister of Public Health that her hospital be issued the requested licences.
She is also hoping for an order of mandamus directing the FDD to consider and/or reconsider her applications.
