Aveo Pharmaceuticals, the Mumbai-based drugmaker which is under scanner for alleged illegal export of unapproved and potentially dangerous opioid and muscle relaxant combinations to West African countries said it never sold such medications in the countries where it is banned.
The company said the combinations of tapentadol and carisoprodol sold under its brand name illegally could be of the counterfeiters.
Arvind Sharma, Managing Director told Moneycontrol that the exports were done only after getting valid product permissions from the , State FDA and required export no-objection certificates (NOCs).
"We are also facing problems of counterfeit as there are several companies who are unlawfully using our brand name and logo, we have already filed multiple legal cases against them in High Court," Arvind Sharma, Managing Director told Moneycontrol.
"Both Tapentadol and Carisoprodol APIs are sold separately in India under valid Drugs Licenses and are not banned anywhere in the world. Recently, after the BBC news some countries have banned the composition of both drugs," Sharma said.
Sharma said exports were done only after getting valid product permissions from the State FDA and required export NOCs, and added that similar approvals were also given to other manufacturers in Maharashtra and other states of India. He also added that the company is exporting the combination drugs to Niger and Burkina Faso for which we it has export NOC from CDSCO.
"It is pertinent to note that our agreement with the buyer is for contract manufacturing and Cost, Insurance, and Freight (CIF) export to the destination port. Distribution, marketing, and pharmacovigilance of the product are the buyer's responsibilities in their respective countries," he added.
Sharma said the combination of opioids and muscle relaxant are currently available in USA.
The Indian government, through the Central Drugs Standard Control Organization (CDSCO) and the Maharashtra Food and Drug Administration (FDA), has taken action against Aveo Pharmaceuticals. This includes raids, seizures of tablets and APIs, and has shutdown the company's factory in Boisar, MIDC Tarapur industrial estate. This follows an investigative story by BBC that found Aveo of illegally exporting a combination of Tapentadol and Carisoprodol to countries like Ghana, Nigeria, and Côte d'Ivoire. This specific drug combination is not authorized for use anywhere in the world.
The CDSCO has already revoked all NOC’s, given to tapentadol and carisoprodol combination.
"We have requested them to provide us sometime, as we have finished and semi-finished stocks in our factory and export obligations from the concerned buyers," Sharma said.
Sharma said the company has submitted a detailed Corrective and Preventive Action (CAPA) plan to State FDA and CDSCO, showing commitment to all compliances and regulatory norms.
"We are waiting for further instructions and request both the authorities to uphold factual accuracy and expedite the resolution, and open our factory as the prolonged closure is severely impacting our business and brand reputation," he added.
Aveo was incorporated in 2015, and its manufacturing facility commenced operations in 2022. It has close to 300 workers both direct and indirect. The company exports drugs to African countries like Kenya, Malawi, Ghana, Nigeria, Niger, Burkina Faso, Sierra Leone, and Guinea, among others.
The company says it adheres to WHO-certified Good Manufacturing Practices (GMP) guidelines, as well as national and international standards and pharmaceutical industry regulations, and has all the required licences and approvals from both State and Central governments necessary for trade.
"We have a strong portfolio of over 400 products and a proven track record of supplying them to both domestic and international markets in the form of tablets, capsules, oral powders, etc," Sharma said.
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