EARAPA REGULATORY NEWS LETTER

Drug Alert || What do repetitive syrup incidences tell us?

Uzbekistan Says 18 Deaths Linked To India-Made Syrup, January 2013

Uzbekistan Cough Syrup Deaths' Claim: The health ministry of Uzbekistan, in a statement, said that the 18 children who died had consumed cough syrup Doc-1 Max - manufactured by Noida-based Marion Biotech

According to Uzbekistan's health ministry the syrup contained a toxic substance, ethylene glycol, and was administered in doses higher than the standard dose for children, either by their parents, who mistook it for an anti-cold remedy, or on the advice of pharmacists.

India's drug regulator said on Thursday that it had inspected a facility that made a cough syrup linked to deaths of the children in Uzbekistan and promised more action based on its findings.

A legal representative of Marion Biotech, the Indian maker of the Dok-1 Max syrup, said the company regretted the deaths and has halted its production

India is known as the 'pharmacy of the world', and has doubled its pharmaceutical exports over the last decade, touching $24.5 billion in the last fiscal year. The frequent incidences of Indian cough syrups show that India need to set strong system for domestic regulation for the pharmaceutical industry. However the biggest responsibility lies on the national regulatory agencies of the destinations. National regulatory agencies of the importing countries need to take care of overseas manufacturing plant and drug product approvals and post market vigilances in their respective countries.

Which East African Regulatory Agency is relatively most stringent? (Applicants view)

According to the pharmaceutical industry players voted to the last poll for the most stringent national regulatory agency in East Africa region, the Ethiopian food and drug authority (EFDA) is selected for the most stringent regulatory agency in the region with 42% (120 votes) out of the total 288 votes and Tanzania TMDA is the second most stringent agency based on the voters opinion 34% (99 votes) , Kenya pharmacy and poisons board (PPB) 16% (45 votes) and Rwanda food and drug authority (RFDA) 8% (24 votes) were found based on the one week poll voted by EARAPA members and followers worldwide.

Kenya

Kenya Pharmacy and Poisons board ordered recall of Anti-HIV drug from the country market, November, 2022

NAIROBI, Kenya, Nov 25 – The Pharmacy and Poisons Board (PPB) and the National HIV and STI control program (NASCOP) has confirmed receipt of several product related market complaints for Tenofovir/Lamivudine/Dolutegravir (300/300/50mg) tablets manufactured by Universal Corporation Limited (UCL).

PPB Chief Executive Officer (CEO) Dr. Fred Siyoi said that following the market complaints related to discoloration of induction seal and discoloration of the tablets, the UCL is implementing voluntary recall of all batches of Tenofovir/Lamivudine/Dolutegravir (300/300/50 mg) tablets from the market as a precautionary measure pending the determination of the impact and extent of the quality concern by the Pharmacy and Poisons Board.

In a statement to newsrooms, Siyoi said that the PPB has collected several samples from healthcare facilities and they have been submitted to the Quality Control Laboratory for further analysis.

“All healthcare facilities are instructed to quarantine all stocks of the product and accept the products returned by clients. Currently, the PPB in conjunction with KEMSA and the manufacturer are coordinating the reverse logistics to ensure all quarantined stocks are mopped up and returned to a central place,” said Siyoi.

Please note that only the Tenofovir/Lamivudine/Dolutegravir (300/300/50mg) manufactured by Universal Corporation Limited is affected by this quarantine and recall as per the PPB officials.

Rwanda

Rwanda Bans Ketoconazole Tablets from Rwanda market.

Rwanda FDA announced with official letter dated on 9th December,2022 that Ketoconazole Tablets intended for treatment of fungal infections shall be withdrawn from Rwanda market.

The authority said, according to the safety assessment done based on national pharmacovigilance data as well as other worldwide evidences, the national pharmacovigilance advisory committee found that the higher risk of liver injury outweighs the benefits in fungal infections treatment and hence , the authority decided for the withdrawal of the drug from market and orders importers, distributors and healthcare service providers to stop distribution and prescribing the drug product, withdraw thier stock and report to the authority within the specified time period.

Rwanda FDA advised to health professionals in the country to use other anti-fungal options in the market for the treatment of fungal infections as appropriate.

EARAPA would like to remind other Authorities in the region to set strong pharmacovigilance follow up to the drug in their respective countries.

Ethiopia

Ethiopian Food and Drug Authority (EFDA) Calls Indian manufacturers for a meeting on 16th Jan 2023.

EFDA invites Indian pharmaceutical manufacturers association and member pharmaceutical companies for a briefing meeting on marketing authorization procedures of the authority and upcoming expediting procedures with official letter signed and issued by Deputy General Director of EFDA Mr. Seyoum Wolde

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East African Regulatory Affairs Professionals Association (EARAPA)

EARAPA

January 2023