THE PILL OVERLOAD

by Carol Aloysius

The population boom, followed by the surge in communicable and non communicable diseases has resulted in a visible spike in medicinal drug dependency in Sri Lanka.

With demand often exceeding supply, most patients find themselves pushed to the wall when forced to fork out thousands of hard earned rupees for a handful of drugs which may or may not cure them of their complaints, depending on their quality and efficacy.

Still, it's a gamble they are willing to take- driven by their conviction that drugs are the ultimate cure for all their illnesses..

According to a report by the Institute of Policy Studies in 2005, it was reported that approximately 9,000 medicinal drugs are registered in Sri Lanka. How essential they are is still a matter of conjecture. Health Ministry sources on the other hand say the number is much less for the government sector. Health Ministry sources said only 1,000 drugs are registered in the hospital formula. Except for 52 drugs which are manufactured locally, the balance is imported. In the case of the private sector the exact extent of drugs imported is a matter of guess work.

How much of these drugs meet the quality standards prescribed both nationally and internationally, we asked?

COPE

An investigative report by the Committee on Public Enterprises (COPE) this week disclosed some startling information regarding drugs imports. The chairman of COPE, Sunil Handunetti in an interview with our sister paper, the Daily News charged that Sri Lanka has imported rupees one billion worth of sub standard drugs in the past five years. He further accused the three institutions responsible for supply and distribution of drugs to the state health care system of lacking proper communication and coordination. He has also said the State Pharmaceutical Corporation ( SPC) did not have the mechanism to conduct checks and expiry dates on medicinal drugs that arrive at the Customs, raising concerns about quality assurance of imported drugs.

Deputy Director General, Medical Supplies Division, Dr Kamal Jayasinghe	Managing Director, State Pharmaceutical Manufacturing Corporation, P. Suntharalingam

Reacting to these charges, the Managing Director of the State Pharmaceutical Manufacturing Corporation ( SPMC) P. Suntharalingam told the Sunday Observer, " We only import raw material for medicinal drugs. We strictly follow procurement guidelines, tender procedure and any other requirement relating to the import of raw material. When there is a need to import raw material, we first place an advertisement for bids. Since they are imported, the tenderers are from all over the world. All bids are open in the presence of the tenderers, and similarly based on the tenders we have pre-bid meetings if clarification is sought for transparency reasons. Next the matter goes before the Technical Committee whose members are from different disciplines - a few from the Corporation and from the Health Ministry. All members are appointed by the Secretary of the Ministry of Health while in all our committees we include a representative of the Health Ministry as well".

Commenting on the recommendation by COPE to devise mechanisms for quality checks at the port of entry, Suntharalingam said "All raw material imported for medicinal drugs, is subject to rigorous testing. It is tested for quality before being given for production Thereafter, each batch is tested after manufacture and only if we are hundred percent satisfied, we release them for distribution to government health facilities," he said.

Former Director Food and Drugs Authority , Dr Hemantha Herat said 14,000 items were on the list of medical supplies. They included medicinal drugs as well as other items such as injectables and, surgical gloves. Regarding drugs, he said the requirements for Sri Lanka being a small country, was relatively, small. Hence the prices quoted would be comparatively high."

Competitive bidding

Pic: indianexpress.com

He explained that in the case of certain drugs, only a very small quantity was required. Sometimes the procedures involved in importing those small quantities may exceed the total drug value and push up the prices to even double the original amount. He said while it was cheaper to import drugs in large stocks which then would also last a longer time, for practical reasons this was not possible.

He said "Due to the high price of imported drugs, we are now going for competitive bidding. Most suppliers are looking at basic standards. If we want something more than that , they will raise their prices. Although drug quality standards are being constantly revised, competitive bidding on our side could lead to suppliers compromising standards. The result would be sub standard drugs."

Because of this he said," We should support the SPC and National Drugs quality Assurance laboratories, to ensure that all essential drugs we import are up to the required standard."

Medical Supplies Division Deputy Director General Dr Kamal Jayasinghe's emphatically denied the COPE charge that the country was flooded with low quality imported drugs. "We have seen a remarkable improvement in the quality of imported drugs and a much less frequency in quality failure", he asserted.

The main cause for this miracle he said was the recently amended rules and regulations which the Lankan government expected all suppliers of imported drugs to adhere to.

Improvement

"Previously, whenever there was a quality failure in the drugs we imported, only the balance stocks were withdrawn and the supplier had to pay the cost of only the remaining stocks. Now that has changed with the new rules. Hereafter, all suppliers of medical drugs have to pay for the total consignment - plus a hefty 25% penalty tax i.e. 125% by way of taxes, if there is quality failure. Since the SPC is the importing agency, we charge the SPC, which in turn charges the suppliers, unless it is due to shortcomings on our side such as poor storage. Hence there is a improvement in the quality of the drugs we import," he said.

Computer network

He said the latest inputs into drug management via a computer network facilitates rational distribution of drugs, cutting down over-distribution and under- distribution of essential drugs. "The computer system connects line ministry institutions and the Regional Medicinal Supplies Division ( RMSD). We are in the process of extending it to provincial institutes shortly, "he said.

How does this help in better drug distribution management, we asked?

"With this system in place, we can effectively monitor distribution of drugs , minimise wastage. In the past two to five years, there have been very few or no expired drugs being reported, as we are now in control and can visualise from the centre," he said.

He noted that in the past they had to imagine and forecast estimates. This was not an accurate method. We noticed supply gaps due to under-estimation and wastage due to over estimation. Now with computers in place, we can do realistic estmates according to actual consumption patterns", he said.

President People's Movement for the Rights of Patients, Louis Benedict, a long time campaigner for quality drugs at an affordable price, said he was happy that the long delayed National Medicinal Drugs Policy ( NMDP) advocated forty years ago by Professor Bibile was being implemented at last, and that a quality drugs assurance lab was being set up, with foreign technical assistance.

" With the number of essential drugs also being reduced, and an upgraded quality lab in the offing, we hope things will change for the better when it comes to obtaining good quality drugs at cheaper prices for all of Lankans.

However, the authorities must keep a sharp lookout for counterfeit drugs that are smuggled into the country in suitcases, and sold at exorbitant prices even though they contain nothing more than plain cornflour or wheat flour. 'Baggage drugs' have become big business and manufactured in small cottages in neighbouring countries. The urgent need now is to eliminate racketeers, get rid of unnecessary brands of the same drugs and streamline drug distribution in this country".

As a solution to the present drug situation, health officials said since drug usage has becoming a daily part of our lives, a rational policy of drugs usage. should be adopted islandwide. "Both the prescriber and supplying agencies should work together for rational drug use in Sri Lanka ", Dr Jayasinghe said.

SPC officials and the COPE chairman were unavailable for comment at the time of going to press, despite repeated attempts to contact them.