11th March 2001
The ills of Pills
900 basic drugs, but 9000 brand names
By Hiranthi Fernando, Tania Fernando and Chandani Kirinde
With increased competition in the Pharmaceutical trade and more companies coming into the field in Sri Lanka, Health authorities are saddled with a problem of controlling the quality of drugs imported.
The pharmaceutical market which topped 10 billion rupees last year is estimated to reach 15 billion rupees this year.
The Sunday Times investigation revealed that the market is flooded with thousands of brands of drugs which makes it difficult to control the quality.
Although the basic chemical entities of the drugs that are imported are confined to around 900, these medicines are sold under 9000 brand names, some of which have become household names.
Certain varieties of popularly used antibiotics, for example Amoxycillin, are available in over a hundred different brand names, according to medical sources. However, the unlimited number of brands coming into the country has led to difficulties in monitoring the quality of these drugs effectively, they said.
There appears to be little facilities for random checking of drugs in the market. When a drug is registered after samples are scrutinized, there does not seem to be any checks on the bulk imports of the same medicine. Hence, there is nothing to prevent an importer submitting a good quality sample for approval, and thereafter supplying a sub-standard drug to the market.
According to medical experts, there are many brands of drugs in the market, which do not have the desired efficacy. A medical practitioner who wished to remain anonymous said when one of his patient's being treated for epilepsy with the original drug Tegretol, switched to a cheaper substitute, he started getting fits again and had to revert to the original drug to control his ailment.
The cost for registering a new drug with the Drug Regulation Authority (DRA) is Rs. 5,000, a comparatively low fee given the huge profits that pharmaceutical companies enjoy. A recent proposal by the DRA to increase the registration fee to Rs. 25,000 was met by angry protests from the industry which said this would lead to an increase in the cost of drugs.
However, DRA authorities say this claim is unjustified since this fee only applies when a new drug is registered and not for existing brands.
Pharmaceutical companies spend huge sums of money for launching new products and for entertaining those in the medical establishment. A recent launch of a drug for the control of high blood pressure was held at a five star hotel, with a large number of invitees. The expenditure to host such an event makes the proposed registration fee of Rs. 25,000 look like a drop in the ocean.
Pharmaceutical companies claim that although the fees for registration are being increased, the time taken to approve a drug is taking longer and longer.
The lack of storage facilities at the DRA is one of the main problems with files containing applications stacked up along the corridors of the building. This is compounded by a lack of qualified personnel to handle the applications.
"Finding a file is a difficult task because they are stacked almost to the ceiling. We need to have a more modern facility especially computers and access to the internet to work more effectively," an insider said.
The State Pharmaceuticals Corporation (SPC) is the largest importer of drugs to Sri Lanka which amounts to 40 percent of imports.
SPC Chairman Prof. Colvin Gooneratne said the Corporation adhered to strict checks on all its imports to ensure quality of products they handle and could not be matched by any other company.
"Short listed tender samples are first tested in our fully equipped laboratory. After the tender is awarded, random samples of each batch supplied are tested. We also test post marketing samples drawn from our 'Osu Sala' pharmacies and other franchise pharmacies as well as samples sent on complaints," Prof.Gooneratne explained.
Registration of drugs in Sri Lanka are done in accordance with the standards set by the World Health Organization (WHO).
Prof. K. Weerasuriya, Professor of Pharmacology, of the University of Colombo who is also the Secretary of the Drug Evaluation Sub Committee, said adequate safeguards are taken before a drug is released to the market. "No regulatory authority can check all the products coming in. However, we have procedures to check whether they are being manufactured properly," he said.
Applications for registering a drug has to be submitted along with a detailed dossier of information on the product. Members of the sub committee examine the dossier and where it is felt that further scrutiny is necessary, the samples are sent to the National Drug Quality Assurance Laboratory for testing.
"We have to go through each drug and check whether the indications given tally with those of the original drug," Prof. Weerasuriya said.The examination of the application for a new drug submitted for registration by a well known manufacturer and importer of drugs recently revealed that certain vital information was left out by the applicant.
The leaflet enclosed in the dossier included under the indications heading that the drug could be used in treatment of nausea and is less likely to cause drowsiness.
However the indications given for the original drug makes no mention of its effectiveness in treating nausea and says drowsiness is likely in those using the drug.
Prof.Weerasuriya said such details had to be accurate because a person using the medicine and driving without realizing it could feel drowsy.It could also be misleading to a doctor prescribing the medicine, he said.
Prof. Weerasuriya agreed that if less brands of a particular drug were available, quality control would be more feasible. However, he said, the regulations do not permit them to restrict the number of brands.
"When we evaluate, we are asked to consider quality, safety and efficacy", he said. "The Regulations do not allow us to look at cost. If we are allowed to consider cost effectiveness, we could overcome some of the drawbacks".
However, importers are of the view that restrictions on the number of drugs being imported and control on their prices would only have a detrimental effect.
President of the Sri Lanka Chamber of the Pharmaceutical Companies Upali Panditharatne said more and more companies were coming into the Sri Lankan market and more competition meant prices of medicines would keep going down.
Mr. Panditharatne said although many brands of a drug are registered, all are not available in the market. Many importers register brands to take part in the tenders for the government hospitals and the SPC.
He said unsatisfactory facilities for the storage of drugs was a problem in many pharmacies. "The manufacturers turn out a high quality product but the shelf life varies with the method of storage. Some drugs and particularly vaccines are sensitive to storage.
Mr. Panditharatne said the fluctuation of the rupee was one of the reasons for drug prices going up. Before, 1994, imports from the SAARC region were paid for in local currency of the producing country, which did not fluctuate much. In 1994, an agreement was signed specifying that payments should be in US dollars and with the depreciation of the rupees, prices went up.
With regard to the sudden non availability of certain drugs, Mr. Panditharatne said manufacturers sometimes stop producing drugs which have less demand in favour of those which have a greater demand.
Many medical specialists felt that it was upto members of the public themselves to act in cases where they have been sold poor quality drugs. The Drug Information Service in Colombo is one place where complaints on drugs could be directed to. This would be done in the peripheries through the medical officer of the area.
The number of complaints recorded in Sri Lanka are rather low, according to a member of the DRA.
Sri Lanka is also linked to an International Drug Monitoring Centre with its headquarters in Sweden. The centre in Australia, with a similar population as Sri Lanka, receives around 12,000 complaints per year on drugs while the Centre in Sri Lanka receives only about 10. There is very little reporting from doctors as well as from patients.
As the arguments between the pharmaceutical companies and government bodies continue on the pros and cons of the subject, it's the patients who have to swallow the bitter pill at most times.
A worrying problem for many in the medical fraternity and the public in general is the high cost of certain brands of drugs which make them inaccessible to the common man.
As cost-effectiveness is not a criterion for drug registration in Sri Lanka, importers are allowed to sell the drugs they bring into the country at prices they fancy.
The only restriction imposed is that they can sell a drug at 168 percent of the CIF value (Cost, Insurance and Freight) of the drug.
However there is no restriction on the value.
An argument for the control of the cost of drugs at the time of their registration is supported by the example given below.
The drug Ranitidine was registered in Sri Lanka by the company which developed the drug and the product made in the U.K. was sold for Rs 30 per tablet.
However, the same company manufactured Ranitidine in India and sold it for Rs three per tablet.
However, the Indian made product was not available in Sri Lanka thus forcing them to use the more expensive drug. As to why the cheaper drug was not imported to Sri Lanka is anybody's guess.
Those who argue against regulating prices, mainly those involved in imports say restrictions could lead to corruption.
They say the hands of the regulators must be strengthened to check the quality of drugs but restricting prices will not benefit the consumers because it could lead to a drop in the quality of the medicines available.
In the final analysis, what drug importers have to decide is whether they are ready to put the people before profits and sell drugs at more affordable prices.
Syringes valued at about Rs. 3.5 million (US$ 41,000) has been dumped at a site in Welisara. These syringes which were imported from a company in South Korea had been found to be faulty.
These syringes which were supplied after a tender was called for by the State Pharmaceutical Corporation was found to be acceptable by the Technical Evaluation Committee. However, after they were distributed for usage, doctors had complained they found drops of oil in the syringes and therefore were reluctant to use it.
After a complaint was made to the Company concerned they had sent replacements to the SPC, which were checked at the Port prior to clearing. According to sources at SPC this too was found to be unsatisfactory and therefore was not cleared.
SPC sources also said to blacklist this company it was necessary to obtain permission from the Secretary of Health. A letter had been sent to the Secretary in April last year and a reminder in January this year, but little had been done.
He further said the company was now not in existence anymore and therefore it was not possible to get a replacement or a refund of the money already paid for this consignment.
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