26 Apr 2014, BioSpectrum Bureau , BioSpectrum
Singapore: Claiming that the drugs supplied by at least 45 Indian pharmaceutical companies are not of standard quality (NSQ), the Drug Administration of Vietnam (DAV) has banned drugs by these firms on its land.
Some major Indian drug makers like Strides Arcolab, Medley Pharmaceuticals, Marck Biosciences, Marksans Pharma and UMedica Laboratories are also part of the list of banned drug makers.
News reports specified that all the companies in the banned list failed the DAV quality tests between January 1, 2011 and October 25, 2013.
Vietnam has also banned drugs from nine Korean companies, two companies from Bangladesh, two from France, and one each from the US, Philippines, Pakistan, Russia, Indonesia, Germany, Cyprus, and Canada.
As per Indian health ministry sources, India is one of the largest suppliers of medicines to South-East Asian countries like Vietnam and African countries like Kenya, Nigeria and Ghana.
Mr Deepak Mittal, the Indian consul general in Vietnam is said to have written a strongly worded letter to the ministry of health and family welfare. Copies of the letter have been sent to the external affairs ministry, the department of commerce, the Indian embassy in Hanoi and to the office of the Drug Controller General of India (DCGI).
Mr Mittal has said in his letter, "In view of the fact that a large number of Indian companies have been listed defaulters by Vietnamese authorities, it is requested that necessary background checks on these companies may kindly be undertaken in India to see if there are complaints against them from other countries and steps be initiated to penalise them for bringing bad name to the Indian pharma industries abroad."
A drug is declared NSQ if the active pharmaceutical ingredient (API) in it is lesser than the declared amount. In such a case, the efficacy of the drug goes down. The other parameters that are checked are the quality of bonding agent, colouring agent, and the time taken for dissolution.
But this is not the first time Vietnam has banned Indian companies. About two years ago, it had banned 19 pharma companies on the same ground, the health ministry source said.
Mr T R Gopalakrishnan, advisor, Indian Drug Manufacturers' Association (IDMA) told news media that, "Vietnam depends on India for procuring drugs. In recent years, Chinese interference in the markets has been observed. But China is not yet at par with India in manufacturing finished drugs. It should be noted that Vietnam hasn't banned any Chinese company."
Mr DG Shah, the president of the Indian Pharmaceutical Alliance (IPA), however said, "Vietnam sources drugs at the cheapest price. And quality is bound to suffer. But if big pharma companies are figuring in the list then regulatory authorities should inspect the quality of their injectibles, tablets, capsules and syrups."