The Pharmaceuticals Market in Sri Lanka: Ending the Chaos

By Dr. Dayanath Jayasuriya, President’s Counsel

In 1949 whist debating the Food and Drugs Bill, Dr. N. M. Perera stated, with almost prophetic vision, that “there has been all sorts of muck, if you will permit the use of the word, labeled under the name of drugs in this country.”

More than 70 years later these words are equally true if one were to look at what is available in some places – drugs banned even in the country of origin, expired drugs, drugs in relabeled packages, drugs unregistered with the regulatory authority, drugs of dubious quality, drugs the importation of which specialist committees have cautioned against and drugs from certain manufacturers not known for good quality production facilities.

The list can be much longer. Public sector hospital pharmacies lack even some of the basic essential medicines. In-patients are asked to bring with them cotton wool to surgical equipment if planned surgeries are to take place. Daily qualified specialists as well as young doctors leave the country in search of greener pastures.

From the late 1950s and early 1960s onward Sri Lanka gradually developed a system for the regulation of pharmaceutical products. Initial efforts were due to the singularly impressive work of Professor Senaka Bibile who developed a hospital formulary to rationalize the availability of drugs in the hospitals. Later during his tenure as the founder Chairman of the State Pharmaceuticals Corporation, he found good and relatively inexpensive sources to partially satisfy the country’s demand for imported drugs.

With trade liberalization in 1978, there was an exponential increase in the number and type of medicines that flowed into the country.

In 1980, Sri Lanka enacted the Cosmetics, Devices and Drugs Act. It was based on the Canadian regulatory system. Provisions in the Act and regulations that were enacted five years later provided the basic model of legislation required for developing countries (see, further, D. C. Jayasuriya, Regulation of Pharmaceuticals in Developing Countries: Legal issues and Approaches, WHO, Geneva, 1985). As the country gradually progressed with the expansion of the health-care system, the Act required further amendments but many years later an ill-advised measure was taken to repeal it lock, stock and barrel.

In early 2005 I published a 156 page book entitled Towards a National Drug Policy: Sri Lankan Perspectives. Its nine chapters enumerated measures to be taken based on good practices.

During the drafting of the National Medicines Regulatory Authority Bill, which later became an Act of Parliament (No. 5 of 2015), various groups lobbying to dilute its clauses were very much active. A few professionals posing as independent consultants or experts either lacked expertise in legal drafting or clearly had conflicts of interest. The strongest lobby was for the exclusion of cosmetics from the purview of the legislation, opening the flood gates to import all kinds of products at great cost to the country.

In 2015, a National Medicinal Drug Policy for Sri Lanka was adopted. Its Preamble stated that “Sri Lanka had a partly written Drug policy from the 1960s. It was “written” as elements of a policy, beginning from selection of drugs for the government drug supply and the Ceylon Hospitals formulary in early 1960s, the Bibile-Wickremasinghe report in 1971, the Cosmetics Devices and Drugs Act (1980). However, there was no comprehensive document. There were attempts to develop a NMDP in 1991 & 1996; while the documents were accepted by the Ministry of Health, they did not reach the final step of cabinet approval.” The Policy stated as follows:

A National Standing Committee will be appointed by the Ministry on the recommendation of the Director General of Health Services, comprising all stakeholders to oversee the implementation of the National Medicinal Drug Policy (NMDP).

The Essential Medicines List will prioritize the medicines that are important. The medicines will be selected according to valid scientific evidence, the disease pattern in the country and cost-effectiveness. A standing committee comprising all stakeholders will be established to define and regularly update the National Essential Medicines List. It will formulate, review and update Standard Treatment Guidelines, Drug Index, the Sri Lankan Formulary and Government Drug procurement Documents.

A pricing policy/ mechanism should be adopted to ensure affordability. Retail pricing should be based on a dispensing fee rather than cost markup. Legislation requiring generic prescribing and allowing cost effective generic substitution with the consent of the patient (and where possible informing the doctor) should be enacted.

The state should provide sufficient funding for procurement and supply of necessary medicines with priority for essential medicines, monitor appropriate use and prevent waste. Public and private sector health insurance schemes will be encouraged to develop reimbursable lists of medicines.

The responsibility for ensuring a continuous availability of Essential Medicines in the country is a shared public/private sector responsibility. The state should continue centralized bulk purchase and supply to its institutions. Preference should be given to local manufacturers in supply of medicines to the state sector. Good pharmaceutical procurement practices and management of the supply chain should be enacted for both the public and private sector. There should be a private/public mix of suppliers to the private sector

The regulatory authority should have transparent mechanisms and adequate human resources. Medicines should be registered based on the criteria of quality, safety, efficacy, need and cost effectiveness. An accredited drug quality Assurance Laboratory should function within the authority with appropriate fees for services keeping with WHO Good Clinical Practice Guidelines.

Once the NMDP is adopted, it will be the responsibility of the Minister of Health on the recommendation of the Director General of Health Services, to appoint the National Standing Committee within three months to oversee the implementation of the policy. This policy will be reviewed, and revised if necessary, in five years.

A few months ago guidelines were issued on the tender process for drug procurement. Work on this commenced in 2004 when I was a founder director of the National Procurement Agency set up by the then President HE Chandrika Bandaranaike Kumaratunga.

Quality control problems with a few drugs manufactured in India have been well documented in the past but what is of concern is that still reports appear.

For instance, The Washington Post of April 4, 2023 had an analysis entitled ‘Just How Dangerous Are India’s Generic Drugs?’ The commentator noted: “For a nation that seeks to claim the mantle of “pharmacy to the world,” India is scandalously short on regulatory oversight. In the last six months alone, its generic cough syrups have killed dozens of children, its eye drops have caused blindness and its chemotherapy drugs have been contaminated. The children who died — mostly under the age of five years — were given Indian-made over-the-counter products contaminated with industrial solvents and antifreeze agents that are fatal in even small amounts.

The eye drops contained extensively drug-resistant bacteria. So far 68 patients across 16 US states have been affected. Three people died, several had to have their eyeballs removed, some went blind, the Centers for Disease Control and Prevention reported on March 21. The Indian company issued a voluntary nationwide recall for the drops.

The Wall Street Journal of June 19, 2023 reported that drug shortages stem from quality problems in Indian factories; eye drops, chemotherapy drugs raise concerns about generic products.

Whilst Sri Lankans have to be thankful to India for a generous credit line to import drugs, importation must be done in a structured manner under the oversight of qualified medical specialists.

The priority now is to rapidly compile an inventory of all drugs available in Sri Lanka. Pharmacies must be under a strict legal obligation to provide within a stipulated time-frame material information of the drugs in stock and new drugs on order. Non-compliance must be severely dealt with without fear or favour. Bespoken software is available to systematically enter the data and then to rationalize by an expert committee through a scientific and transparent process what is needed and how gaps need to be met. Otherwise, Sri Lanka will soon become just another junk yard of unwanted and hazardous drugs, negating all the gains from the time of Bibile and other trail-blazers who did their best to ensure that Sri Lanka has one of the best drug regulatory and health-care systems in the developing world.

(The author has advised more than three dozen countries on drug regulatory issues and has published four books and over 50 articles on the subject).