Local manufacturing or local packing of drugs in Sri Lanka?

By Prof. O.A.Ileperuma

Recently, there has been much hype about drug manufacturing in Sri Lanka with State Pharmaceutical Manufacturing Corporation (SPMC) claiming to commence the production of flucloxacillin, in Sri Lanka. This adds to the list of drugs which the SPMC claims to “manufacture” locally along with common drugs like paracetamol and antibiotics like ampicillin. The use of the term manufacturing is a misnomer since what is actually done is getting the drug powders from abroad including the hard gelatin capsule and packing them here. Hence a more appropriate classification is “Packed in Sri Lanka”.

While I am not trying to belittle what SPMC is doing, the real achievement would be to actually manufacture these drugs from raw materials instead of importing the already prepared drug. Chemical synthesis is the key to this and very often these can be carried out on a small to medium scale if proper equipment can be imported. We can tap the unemployed graduates with a chemistry background and employ them for a useful purpose. Carrying out the synthesis even on a small scale many times is possible with the availability of abundant manpower.

 We spend nearly Rs. 20-30 billion annually on importing pharmaceuticals and if surgical items are included, this increases to around Rs. 50 billion. It is pertinent to ask why simple formulations like creams, ointments and syrups cannot be made in Sri Lanka by importing their raw materials. The authorities should ban or restrict the importation of the finished products such as these and also instruct the private pharmaceutical companies to produce them locally.

Sri Lanka lags behind India, Pakistan and even Bangladesh in the pharmaceutical industry. We simply import the raw materials in the form of chemicals and do the mixing and pressing to produce tablets or capsules here. No attempts are made to at least to partially carry out some manufacturing involving chemical synthesis. Paracetamol tablets where the active component is chemically acetaminophen can be easily made from simple compounds like aminophenol and acetic anhydride which can be carried out even in a school laboratory. The other ingredients in a paracetamol tablet are inert ingredients such as starch, potassium sorbate, talc and stearic acid. Out of these, some like starch and stearic acid can be locally made. What the SPMC is doing is to actually import all these chemicals and press them into tablets here. If at least part synthesis of some of these chemicals can be done here, it will help to create employment for unemployed youth and also reduce the price of drugs.

Nearly 30 years ago, I wrote to the then Chairman of the State Pharmaceutical Corporation about the possibility to make the anticancer drug, cisplatin, starting from basic raw materials. I have prepared this compound many times in the past for my research both here and abroad but as expected I did not even receive a reply. Had they accepted my proposal, this drug could have been produced for one-fourth the price of the imported drug.

What is even more hilarious is that saline which is a solution of common salt in water is still been imported although there is some information that this will soon be locally produced. We heard about a proposal to build a saline factory at Padukka in 2015 which promised to make the product available from 2017. I can remember that on August 19th of this year, State minister for Pharmaceutical production telling the media that local saline production will start before the end of the year. Even at the end of the year there is no sign of local saline Now another company is planning to manufacture saline in 2021 at Koggala and I hope the same fate will not happen to this venture as in 2015. Even a 1% sodium chloride (common salt) solution used as a nasal spray is imported from Bangladesh! Are our people in charge of manufacturing drugs incapable of dissolving common salt in water? Or else, maybe they are scared of the powerful lobby of pharmaceutical importers who are financially benefited by importing these simple products like saline and nasal drops.

Most of the antibiotic injections supposedly “manufactured” in Sri Lanka are imported products and only filling them into vials is done in Sri Lanka. The process for the manufacture of antibiotics involves fermentation where specific microorganisms are grown in large containers in a liquid growth medium. Surely, there are enough microbiologists in Sri Lanka capable of carrying out these processes which will enable us to produce the antibiotics we need.

We need to explore the types of raw materials we import and study their substitution with local products. For instance, calcium carbonate which is used to treat osteoporosis and also as an inert additive in many tablets can be easily manufactured in Sri Lanka. We have a good quality calcite deposit at Balangoda and this can be used to prepare precipitated calcium carbonate required for the drug industry. Similarly, magnesium carbonate deposit found in Wellawaya or even dolomite can be used to prepare magnesium carbonate which is used in various antacids and also can be used to produce magnesium hydroxide popularly known as milk of magnesia and used as a laxative.

Indian drug industry imports around 70 per cent of their total bulk drugs from China. Last year, country’s pharmaceutical industries imported 2.4 billion US dollars’ worth of Chinese drugs and intermediate raw material chemicals.  Recently the Indian Government has requested the drug industry to start manufacturing 38 essential chemicals required for the drug industry in India. What is imported to Sri Lanka are the finished products from the Indian drug companies. The same is true of the drugs we import from Pakistan and Bangladesh. The question arises as to why we cannot manufacture all drugs locally from raw materials imported from China since what Indian companies do is to import the raw materials from China, make the drugs and sell the finished products to Sri Lanka.

State Pharmaceutical Corporation (SPC) was established in 1971 and Prof. Senaka Bibile was its first chairman. It had the mandate to import drugs for use in hospitals. In 1987, State Pharmaceutical Manufacturing Corporation was established for the manufacture of drugs and it has succeeded in manufacturing about 50 drugs. This is far less compared to about 350 varieties of drugs currently imported to Sri Lanka. Why you need two corporations to deal with pharmaceuticals is another question. Perhaps the Government wanted to create two Chairman posts just to satisfy the need to please political supporters. I believe that it is beneficial to merge these two corporations and work towards the common goal of providing all drugs needed for Sri Lanka.

What we need is an expert panel of scientists who have no vested personal interests or political ambitions, and Sri Lankan expatriates who have experience in drug manufacturing to formulate a national action plan to manufacture drugs required for Sri Lanka. Concurrently, the production of chemicals required for drug formulations is an urgent necessity where chemists play a major role.