Many essential and life-saving drugs are to be withdrawn from Sri Lanka, while some have already been pulled out mainly due to price slashes imposed by the National Medicines Regulatory Authority (NMRA), the Sunday Times learns. With the big pharmaceutical companies terrified to talk to the media fearing repercussions, serious concern is being expressed in [...]

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Many essential drugs being withdrawn from Sri Lanka

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Many essential and life-saving drugs are to be withdrawn from Sri Lanka, while some have already been pulled out mainly due to price slashes imposed by the National Medicines Regulatory Authority (NMRA), the Sunday Times learns.

With the big pharmaceutical companies terrified to talk to the media fearing repercussions, serious concern is being expressed in health circles that Sri Lanka would be left with substandard and untested drugs which would cause prolonged illness and death in many a patient.

“Some products were moved out last year and others are on the verge of being withdrawn because of price control and also the lack of a mechanism to adjust drug prices for exchange losses in view of the fall of the rupee against the dollar and global increases in production costs,” a source said, adding that big pharmaceutical companies based abroad could not deal with ad hoc pricing.

The products on the verge of being moved out of Sri Lanka are:

  • Alimta 100mg and 500mg injections (Pemetrexed) of Eli Lilly France – an oncology medication for lung cancer.
  • Voltaren SR 100mg (Diclofenac Sodium modified release tablets) of Novartis Switzerland – a non-steroidal anti-inflammatory drug (NSAID).
  • Januvia 100mg (Sitagliptin Phosphate) of MSD Italy – to control diabetes.
  • Rocephin 1g injection (Ceftriaxone injection) of Roche Switzerland – an antibiotic particularly effective for meningitis (an inflammation of the membranes surrounding the brain).
  • Herbesser 30mg, 60mg and 90mg (Diltiazem) of Tanable Japan – for heart disease.

The Sunday Times also learns that even several varieties of insulin, a dire need of diabetics, may be withdrawn shortly.
Meanwhile, the Sunday Times understands that even though NMRA officials were adamant that big pharmaceutical companies had not withdrawn their products, the following products had been pulled out last year (2017).

They are:

  • Tenormin 25mg, 50mg and 100mg tablets (Atenolol) of Astra Zeneca Switzerland.
  • Cozaar 50mg tablets (Losartan Potassium) manufactured by Merck Sharp & Dohme (MSD) of the United Kingdom (UK).
  • Hyzaar tablets (a combination drug of Losartan Potassium 50mg and Hydrochlorothiazide 12.5 mg) manufactured by MSD UK.
  • Fosamax 70mg (Alendronate Sodium) of MSD UK.
  • Binozyt 250mg capsules (Azithromycin) for adults and Binozyt powder for oral suspension 200mg/5ml of Sandoz, Bangladesh.

While Tenormin is for heart disease; Cozaar and Hyzaar are both for the control of hypertension; Fosamax is for osteoporosis; and Binozyt capsules and its paediatric powder are antibiotics.

The prices of 15 essential medicines including neurological and diabetes drugs and intravenous antibiotics as well as 10 anti-cancer drugs were cut recently by the NMRA, while in October 2016, the prices of 48 drugs were slashed.

They included medications used in the treatment of non-communicable diseases (NCDs) such as diabetes, ischaemic heart disease, high blood pressure, high cholesterol and bronchial asthma; antibiotics; and others used for gastrointestinal ailments, hormone disorders and common psychiatric problems.
The price-cuts came under a Maximum Retail Price (MRP) formula set by the NMRA. However, many were of the view that no one knows how it was worked out and at different times different formulae seem to be used.

Several doctors who spoke to the Sunday Times on condition of anonymity said that the country and its people would be in trouble if these medications were withdrawn. Conceding that there needs to be a proper pricing formula for medications and the pharmaceutical industry should not be allowed to fleece the patients, they stressed, however, that it is the right of Sri Lankans to have access to quality medicines.

They pointed out that many patients who did not recover when given the generic of some drugs, were pulled back from the brink of death when the original drug was given. Of course, the authorities will be quick to point fingers and say that the doctors are in the pay of big pharma but that is not true. “There may be a few bad eggs, but for a majority of us, the patients’ welfare is very important,” one source said.

The need of the hour is for Sri Lanka to quickly acquire the ability to test drugs through a good laboratory, other sources pointed out, adding that instead the NMRA and the Health Ministry were just shouting about the price reductions but no one knows the impact it is having on the humble patient.

Of course, the patients would not know whether the medications are working or not, other doctors told the Sunday Times, adding that in the case of NCDs against which Sri Lanka is shouting from the rooftops, people will have to keep changing the medications haphazardly. What of the impact on the patients then, they queried.

Several patients also said that when they took certain medications, they did not recover, but other medications worked. A few sources in the pharmaceutical industry warned that if the dollar went up further, many other quality medicines would also disappear from Sri Lanka. The challenges will arise long-term, as short-term there are stocks. There will be re-evaluation whether these medications would continue in 2019 and the challenge for the local partners of big pharmaceutical companies will be re-negotiating, with the rupee on a downward dive.

“When the pricing in a country with a small market is unpredictable, we as importers have to cajole the companies, but that is becoming more difficult,” said a source, adding that there needs to be a balance between controlling prices and bringing in quality medications.

Another source said everything could not be compared to the cheapest generic. “Yes, the price is important but the balance is whether it can be sustained and we must get out of the thinking that all highly-priced products are bad. This could lead to a dangerous situation where quality is razed down. With lots of products being able to get fake papers, the quality testing needs to be thorough – it should not be just the sample provided by that company which obviously would give a good sample but there should also be random quality checks on products available in the market.”

“We also need to move forward from the polite discussions we have had with the NMRA and look at the reality,” stressed another source, questioning why the registration fee for a medication is charged in dollars by the NMRA. “Then the price of that medication too should be set in dollars,” the source added.
Attempts to contact the NMRA failed.

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