The National Medicines Regulatory Authority (NMRA) has denied allegations (6 January) made by several medical trade unions regarding its participation in a recent controversial tour to India with Health Minister Keheliya Rambukwella, where a team of officials had inspected several pharmaceutical manufacturing plants.

Responding to a question by The Sunday Morning, the NMRA claimed that there had been no ethical shortcomings in its conduct during the said tour.

During the past two weeks, questions have been raised by the health sector trade unions, including from the Academy of Health Professionals (AHP), over the accountability and independence of the NMRA, following the recent revelation of the approval granted for a controversial purchase of medical supplies from an unregistered Indian supplier on an ‘urgency basis’.

The health sector trade unions alleged that one of the overseas companies with which an order had been placed was to procure medicines that were already being produced in Sri Lanka by local manufacturers. 

Further, the unions alleged that the company in question had been blacklisted by the State Pharmaceuticals Corporation (SPC), while the other company which had been granted a procurement order was not registered or validated by the NMRA to produce drugs for local usage.

NMRA justification

Speaking to The Sunday Morning, NMRA CEO Dr. Vijith Gunasekera justified his recent visit, claiming that he had the authority to inspect the plants and that his authority could not work in isolation.

“I’m the authority. That is my Minister. Different people, individuals, and groups can have different opinions. I’m dealing with over 1,000 companies; every day they come to meet me and bring their issues or whatever problems they have. I am constantly in touch with the private sector; why not this one? Can an authority or a regulator work in isolation? I have to be with them. This is one such incident,” Gunasekera explained, responding to a question.

AHP raises questions

Academy of Health Professionals President Ravi Kumudesh however questioned how an independent regulator considered it ethical to join the political representation of the country to inspect a pharmaceutical company overseas – in this case, India.

“How do we justify that?” he queried, urging the Government to launch an independent investigation into the conduct of the NMRA official and the incident.

Kumudesh also told The Sunday Morning that the Minister of Health was now saying that as the Indian Line of Credit (LOC) had not been properly utilised, the remaining funds would soon expire and therefore to avoid such an occurrence, he had spoken to the Indian High Commission and got it delayed for another three months.

According to Kumudesh, as the funds should be utilised within the three months, the Minister had skipped the usual process and held discussions with an Indian company to import the necessary medical supplies.

“There are a few questions regarding the incident. We have been saying this for 11 months – the procedure had been formulated not to purchase medical supplies with the cancellation of tenders and nothing moved forward. But nobody responded. Who should be responsible for not being able to procure goods under the Indian LOC for 11 months? Shouldn’t that be the Health Minister, the NMRA, and the Health Ministry?

“What we know is that it is the NMRA that should take the responsibility as most of the supplies that were to be procured under the Indian LOC were not registered in Sri Lanka and even when the registration was requested from the NMRA, the consultants who are involved with the European medicine mafia did not validate those registrations. As a result, instead of speeding up the process, it got delayed. Due to this, the tenders were not processed and the SPC threw away the file without finding out where the fault was. Those who face the issue should address that, but what the SPC did was cancel the tender instead of raising the issue and resolving it,” Kumudesh claimed.

NMRA role

The NMRA is an independent authority in the Ministry of Health, established in 2015 through an Act of Parliament. It plays a leading role in protecting and improving public health by ensuring that medicinal products available in the country meet applicable standards of safety, quality, and efficacy. The authority regulates medicines, medical devices, borderline products, clinical trials, and cosmetics. 

The National Medicines Quality Assurance Laboratory (NMQAL), charged with ensuring the quality of medicinal products, also functions under the purview of the NMRA.

As learnt by The Sunday Morning, the NMRA has a Code of Conduct which sets out the standards of conduct to be observed by all NMRA staff, including members of the board and external experts. The aim of this integrity policy is to ensure that board members and staff continually maintain and improve their integrity, impartiality, and independence in order to guarantee the quality of the NMRA’s work and decision-making.

SLCPI raises concerns

The Sri Lanka Chamber of the Pharmaceutical Industry (SLCPI) also questioned the conduct of the NMRA, recently raising concerns over media and social media reports stating that the Health Minister had obtained Cabinet approval to purchase a large number of pharmaceutical products for use in the health sector from two manufacturers in India on an urgent basis.

It highlighted that the reports specifically stated that neither the manufacturing sites nor the products to be purchased had been registered with the NMRA, which is the sole and final authority that determines what pharmaceuticals are to be imported and used in the country.

In a letter addressed to the NMRA, the SLCPI quoted news reports stating that the Health Minister had personally visited India in relation to procuring these products and that the agreement had been finalised.

While seeking clarifications regarding the media reports, the SLCPI also stressed that such actions gave rise to serious concerns in the industry and set a dangerous precedent. It also questioned whether those actions were in line with the NMRA Act of 2015.

Indian LOC

In order to strengthen Sri Lanka’s food, health, and energy security, the Government of India extended a concessional loan of $ 1 billion to the Government of Sri Lanka, through the State Bank of India on 17 March 2022.

According to the Indian High Commission, the facility is operational and food items like rice and red chillies have already been supplied under it. Several other contracts for supply of sugar, milk powder, wheat, medicines, fuel, and industrial raw materials, based on the priorities of the Government and people of Sri Lanka, have been included under the facility.

According to the Health Ministry, of the $ 1 billion LOC offered to Sri Lanka by India last year, $ 200 million was allocated to the Health Ministry and of that, around $ 40-50 million remains unutilised.

Giving reasons for the non-utilisation of such funds, the Health Secretary mentioned the long process associated with procurement under the credit line, which was delaying the process more than usual.

Complicated guidelines

However, questioning who had formulated those guidelines, AHP President Kumudesh said: “The credit line process was formulated by Sri Lanka and not by India. Why did they formulate such a complicated procedure? There is a very simple process available under some other funds. Who should be responsible for going for such a complicated procedure when there are plenty of other options available?”

In such a backdrop, Kumudesh alleged that the Health Minister had said that since he had to import medicine within three months, he had left for India. “Before he went, he should have queried whether these pharmaceuticals were being produced in Sri Lanka or not. The majority of these drugs that they are going to import from India are being produced in Sri Lanka. If this is fully open for Indian multinational companies, the companies that are currently engaging in drug production would have to close down their operations,” he continued.  

Highlighting the NMRA’s procedures, Kumudesh stressed that when a pharmaceutical was produced in Sri Lanka, the NMRA usually took months, and in some cases years, for validation.

Minister denies charges

Nevertheless, in December, Health Minister Rambukwella denied allegations levelled against him, claiming that no misappropriation or misdeed had occurred in the process and that he had reimbursed the airfare paid by a ‘friend’.

The Government had reserved $ 60 million to import medicines required for the next three-month period, Rambukwella told the media in Colombo, adding that since the Indian credit line was to expire on 22 November, he had made a personal request for it to be extended to 31 December 2022.

The Health Minister meanwhile told The Sunday Morning that he had visited not just two companies but four companies in India.

Denying the allegations against him, the Minister said that none of the companies had been blacklisted at present while one company had had some of its products suspended.  

“There are over 100 that have been suspended. One of the top companies in the world is Pfizer, but even in that company some of the products have been suspended at some point. This particular company had 250,000 bottles of syrup and towards the end of the expiry date, there were 37 bottles that were left which had some moisture in them, so they were suspended. I corrected that in Parliament on Thursday (5),” Rambukwella said.

“We haven’t ordered anything. We haven’t even given a purchase order. There is an accusation saying that some pharmaceuticals manufactured in Sri Lanka are being ordered. Let’s say that’s right. But for instance, if the requirement is one million and local ones give only 500,000, then the rest must be ordered,” he continued.

When asked about the visit of NMRA’s CEO, the Minister said it was the authority and he wanted the authority to come and have a look at it.

“The whole thing revolves around the issue of requirement; when we called for tenders, 26 local companies submitted applications. A total of 136 items are required. Only three companies came forward for three items and out of those three, two companies came late and said they could not produce because of a payment issue. But I have to give medicine; I can’t give excuses to the people. If the local products are available, preference will be given to them – there is no question about it,” he added.