KATHMANDU, Jan 14: While several Valsartan drugs used by hypertension (high blood pressure) and heart patients have already been recalled in various countries including the US because of some impurities in the key ingredient, they are still being sold in Nepal and the authorities say they are unaware of the impurities.
The US Food and Drug Administration (FDA) has classified some Valsartan medicines as “probably human carcinogen’’ after those medicines were found containing the chemical N-nitrosodiethylamine (NDMA), which can cause cancer in humans.
Nepali drugs regulator, Department of Drug Administration (DDA), however, said it does not have any information on the quality of Valsartan medicines in the Nepali market nor has it taken any initiative to study the impurities.
Even several months since an international ban, Valsartan medicines are still being produced and sold by Nepali pharmaceutical companies.
“Some Valsartan tablets are available in our market,” Santosh KC, senior drugs administrator at the DDA, told Republica. “But we are unaware about the medicines recalled in other countries.”
On December 31, 2018 Aurobindo Pharma USA Inc announced to recall 80 lots of its Amlodipine Valsartan, Valsartan HCTZ, and Valsartan tablets from the market. In the third week of December, Teva Pharmaceuticals announced to voluntarily recall two blood pressure drugs, Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) tablets, due to an impurity.
In July, 2018 the Ministry of Public Health in Doha recalled seven drug products containing ingredient Valsartan that was manufactured by Chinese company Zhejiang Huahai Pharmaceutical L T being sold in the Arabian countries, on suspicion of containing carcinogen.
The list of recalled products includes Cinfaval and Co-cinfaval manufactured by Spanish Cinfa Laboratories, as well as Diostar and Diostar plus manufactured by Jordan’s Pharma International Co in addition to Anginet and Co-Anginet produced by the Jordanian United Pharmaceuticals Manufacturing Co and Valzaar manufactured by the Indian Torrent Pharmaceuticals.
Valzaar manufactured by the Indian Torrent Pharmaceuticals is registered with the DDA and is distributed by Pharmachem Pvt Ltd in Nepal, according to the DDA records. “It is available in the market and still being sold,” said KC.
According to the DDA, 99 products of Amlodipine Valsartan, including 63 domestic and others mostly Indian, are registered with the DDA. Similarly, 23 items of Valsartan HCTZ including 21 domestic and two Indian are registered with the DDA.
More than a dozen domestic manufacturers including Nepal Pharmaceutical Lab (NPL), Quest, Lomus, Omnica, Sumi, Elite and National produce a variety of medicines for hypertension in Nepal. However, DDA officials refused to disclose the names of manufacturers producing Valsartan tablets.
“We don’t have a system to examine the impurity nor the manufacturers have reported to us anything about the quality of such drugs,” said KC.
“The Drug Act 2035 BS does not elaborate on such matters. We drafted a new amendment to the Act and submitted it to the Ministry of Health and Population about a year ago but it has yet to be forwarded to the parliament,” KC said. “We will study the case and begin the process to recall impure medicines from the market,” he said, adding that the importers as well as domestic manufacturers should also act responsibly as the issue is serious.
The DDA informed that 51 domestic manufacturers have been producing a variety of medicines including some for heart-related problems. According to the Association of Pharmaceuticals Producers of Nepal (APPON), 60 percent of the drugs needed in Nepal is supplied by domestic producers.
“Our products are of good quality while many Valsartan products from India have been recalled for impurity,” claimed Dipak Dahal, president of the APPON, while also admitting that the raw materials for Nepal are imported from India and China.
Dahal also admitted that the quality of domestic products is not examined in the government labs. “What can we do when even the DDA does nothing?” he said.
Renowned cardiologist Dr Bhagawan Koirala said that the DDA should examine the quality of raw materials being used by Nepali pharma companies and find out where they are imported from. “The matter related to impurities should be checked and regulated by the DDA,” said Dr Koirala, adding that a few Valsartan products were recalled in the international market.
He, however, argued that despite the recalls, patients need not be frightened. “The patients should not stop taking their medicines as stopping medicines abruptly will be more harmful and their condition can turn critical,” he said, suggesting to doctors and patients to use alternative medicines of Valsartan.
Alternative medicine could be another Valsartan product or a different medication from the same class of drugs, known as angiotensin receptor blockers including losartan, olmesartan, irbesartan, and others, according to the FDA.
The US Environmental Protection Agency (EPA) says NDMA impurity, which was formerly used in the production of rocket fuel, antioxidants, and lubricant additives, forms during both industrial and natural processes. According to the EPA, exposure to high levels of NDMA may also cause liver damage in people.