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Abusing the Section 109 of the National Drug Regulatory Authority Act

The Sri Lankan healthcare system is facing a dire and alarming issue, as a fraudulent medical supplies mafia has been operating with devastating consequences.

By Madhuri Ranasinghe

Recent revelations by Dr Kapila Wickramanayake, Director of the Medical Supplies Department, have shed light on a shocking incident involving a stock of aspirin pills procured from a local manufacturer for government hospitals.
Has the Medicines Regulatory Authority unknowingly approved these medicines? Tragically, these pills were found to lack their main ingredient, salicylate, leading to a circular being issued to remove the faulty stock from hospitals.
The revelation raises significant questions and concerns. How did such a blatant fraud occur without a laboratory quality test being conducted prior to distributing the medicine to government hospitals?
The implications of such negligence are severe, especially for heart patients who rely on aspirin to prevent heart attacks. Accountability must be established, and those responsible for this fraud must face the consequences of their actions.
The root cause of this medical supply crisis lies in the drug mafia that has plagued Sri Lanka for a considerable period. The absence of a well-defined national policy on health and medicine has allowed the mafia to thrive in the shadows, perpetuating illegal activities.
The drug mafia seems to resurface intermittently, often influenced by the shifting political landscape. Under the current Minister of Health, Mr Keheliya Rambukwella, the drug mafia appears to be rearing its ugly head once again, resulting in tragic consequences.
Recent reports have revealed harrowing cases of patients suffering severe health issues or even losing their lives due to medicines which are not up to the standards. Shockingly, some patients have gone blind after using eye medicine, while others have succumbed to complications caused
by antibiotics imported from India.

The news that people are dying and people are going blind due to inferior medicines started to spread like a wave along with the media reports that nearly 10 patients of the National Hospital and Nuwara Eliya Hospital became blind after using the eye medicine called ‘prednisolone’.
The additional health secretary told the media that a group of bacteria was found in the stock of eye medicines that had been obtained from a manufacturer in the state of Gujarat, India. Where is the problem? Now the question we have is whether the National Drug Regulatory Authority or the Medical
Supply Division or the Ministry of Health is not responsible for these deaths. Their statements imply that they have no responsibility in this regard. For example, a tender to bring insulin has been given to an Indian company, which is a registered company in Sri Lanka. Even in a normal situation, Sri Lanka imports the largest amount of
medicines from India. There is no problem in importing medicines from registered companies. The problem here was importing medicines from unregistered companies. The lack of proper regulation and oversight in medicine procurement has enabled unregistered
companies to supply substandard medicines, jeopardizing the health and well-being of patients. According to the opinion of the expert doctor, what is happening now is the importation of medicines for the needs of the Ministry without any regulation. The National Drug Regulatory
Authority has devolved its duties to the Ministry of Health. Abusing the Section 109 of the National Drug Regulatory Authority Act It is the main opinion of health experts that what is happening is the importation of drugs at will by abusing Section 109 of the National Drug Regulatory Authority Act. The National Drug
Regulatory Authority is justifying its current behaviour under Article 109. The Association of Government Medical Officers expressing their views on this issue also states that they are importing medicines by misusing Article 109. According to the opinion of the
Government Medical Officers Association, more than 700 medicines have entered the country under the WOR or Waiver of Registration system in the last year 2022. At the time of writing this article in the year 2023 (24), that number is more than 500.

The situation is further complicated by the practice of importing medicines under the Indian credit line. While procuring medicines from India can be beneficial, the lack of stringent regulations and adherence to registration standards has allowed fraudulent medicines to enter the country, posing
a grave threat to patients. The National Drug Regulatory Authority’s failure to fulfil its duties and its willingness to approve medicines from unregistered entities without proper evaluation is deeply concerning. It is essential to hold these authorities accountable for their actions, and they cannot absolve
themselves of responsibility for these medical tragedies. The 2021 audit report conducted by the National Audit Office on the National Medicines Regulatory Authority (NMRA) has exposed a concerning breach of the Act’s stipulated conditions.
The report sheds light on the issuance of letters of exemption for registration to both the State Pharmaceutical Corporation (SPC) and private institutions, allowing them to import 67 medicines and 140 medical equipment without proper registration.
These exemptions were supposedly granted due to reasons such as the cancellation of registration or a lack of registered suppliers, which, upon closer examination, do not qualify as legitimate circumstances for exemption.
A revealing Daily News article (Source: https://www.dailymirror.lk/opinion/Purchasing-of- medicine-How-Health-Ministry-initiated-ploys-to-enjoy-lofty-commissions/231-264662 ) includes insights from an anonymous source within the ministry who disclosed numerous instances of
emergency purchases being made without adhering to the proper procurement procedure. Shockingly, these purchases were conducted with the full knowledge and involvement of the Ministry of Health, the State Pharmaceuticals Corporation (SPC), and the NMRA, bypassing the
existing stocks available with the Medical Supplies Division (MSD). These revelations paint a concerning picture of a system where exceptions and loopholes are exploited, undermining the regulatory process and potentially jeopardizing the quality and safety
of medical supplies reaching the public. The lack of transparency and adherence to procurement protocols raises questions about accountability and highlights the urgent need for systemic reforms to safeguard public health interests.
Experts in the medical field insist on an urgent change in the national health policy and strict enforcement of drug regulatory laws. Impulse purchases of medicines must be replaced by a well- structured system that prioritizes the safety and quality of imported medicines. Additionally, the

government must take comprehensive measures to address the drug mafia issue and develop a robust national policy on health and medicine to protect the welfare of its citizens. This fraudulent medical supplies mafia in Sri Lanka poses a critical and urgent problem that
demands immediate action. By implementing proper regulations, ensuring accountability, and formulating a strong national health policy, Sri Lanka can combat the drug mafia and restore confidence in its healthcare system. Only then can the nation safeguard its citizens from fraud and
deception and provide them with the high-quality healthcare they deserve.