Drug Regulatory Authority (DRA) recently informed the general public to avoid the use of four substandard paediatric medicines that are, Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
The World Health Organization (WHO) had issued an alert on the four types of cough and cold syrups exported by an Indian pharmaceutical firm linked to the deaths of 66 children in Gambia.
The unit of Maiden Pharmaceuticals that manufactured the syrups is located in Sonipat, Haryana in India.The Haryana Food and Drug Administration said it was preparing to test samples of those medicines.
The four products may have been distributed, through informal markets, to other countries or regions. WHO advised all the countries to remove these products from their markets. WHO has pitched for increased surveillance within the supply chains of countries and regions likely to be affected by these products.
“Increased surveillance of the informal/unregulated market is also advised,” the WHO statement said.
An official from DRA said so far, these four products of Maiden Pharmaceuticals Limited are neither registered with the DRA nor imported into the country. In the past, there were few products registered from Maidan Pharmaceuticals Limited but after contacting the suppliers, DRA was informed that the suppliers have already stopped dealing with the Maidan company a long time back. However, not a single product has been imported into the country to date.
Therefore, the general public should not panic over this although Bhutan imports 90 percent of its medical products from India.
The official said all the medical products imported into the country are registered through technical and regulatory scrutiny to ensure safety and quality. DRA goes through two ways of checking any medical products, which are pre-marketing and post-marketing. For any medical products, the dealer has to register with the DRA and they will do the necessary dossier of the particular products. The dealer also has to submit samples of the products.
After all the dossiers, DRA will review those documents first based on the criteria, and the individual product is sent for a sample test to Royal Centre for Disease Control if any doubt in the quality of the product. And if the product is found to be substandard after the sample test, and if the applicants have doubts, and want to appeal then the product is further sent to India or Nepal for a sample test.
After registering for any medical products, DRA issue a certificate of the product and an import authorization letter for every consignment. No applicants can bring in any medical products without import authorization, said the official.
“We have collaboration with the customs, if any dealers are found with no import authorization from DRA, then the products will not proceed further into the country,” said the official.
The official said that after the medical products are in the market, DRA ensures that they go for routine inspection and ad-hoc inspection, even in the pharmacies.
In the post-marketing, random sampling will be done, where critical drugs are sent for testing. Furthermore, private pharmacies maintain the complaints received from the customers on a particular product, in terms of quality or any adverse effect, and it is then sent it to DRA for further review of the products.
DRA has a National Pharmacovigilance Committee, which collects the report and analyzes and confirms whether the cause is because of the particular product and submits it to WHO.
If there is any complaint about the products in the market, sometimes the complaint is about the quality of the product, “We also have a recall committee, if the products are already distributed across the country, the recall committee will come into action,” said the official.
So far, there have been no complaints received from consumers or any private pharmacies on any medical products. “I don’t know if either the consumers are less bothered or maybe the quality is good,” the official added.
DRA also looks into manufacturing companies when the applicants come for product registration. The applicants must provide company details while registering for any products.
Meanwhile, there are about 26 wholesalers and retailers in the country. 90 percent of the medical products are imported from India and the rest from Thailand and Bangladesh.