Several Indian pharmacies continue to sell antihistamine and motion sickness medicine buclizine to boost children’s appetite, despite a government order three months ago to ban this particular use of the drug “in public interest”, shows a new survey. The survey, conducted by a private investigation agency, also claims requirements to clearly mention that the drug should not be sold for this purpose have not been followed for the samples examined.
The findings have caused a public health activist to urge the Delhi High Court to direct the government to initiate “criminal” proceedings against the medicine’s manufacturer — Mankind Pharmaceuticals Ltd.
In December 2018, the Health Ministry prohibited the use of buclizine as an appetite stimulant, stating it is “likely to involve risk” to human beings. It also directed manufacturers to mention “in conspicuous manner” on the drug’s package insert and promotional literature that it was “not to be used as appetite stimulant”.
However, over 170 pharmacies in Delhi, Gurgaon and Hyderabad, including those attached to hospitals, continue to sell ‘Longifene’, Mankind’s brand of buclizine, for this indication, the survey conducted in February found. The investigator was hired by activist Dinesh S Thakur, the whistleblower who exposed wrongdoing at Ranbaxy.
“Despite the unambiguous directions issued by the Central Government … the appellant was shocked to discover that the old stock of buclizine have not been recalled from the retail market, and moreover, no label or stickers containing the disclaimer have been affixed on the packaging,” stated Thakur in a fresh application to the Delhi High Court. The Indian Express has reviewed a copy of this application.
“None of the pharmacies surveyed by the investigation agency were aware of the prohibited use of buclizine as an appetite stimulant or the associated health hazards,” the application stated.
Thakur has alleged the survey “disclosed the commission of a cognizable offence” under India’s Drugs and Cosmetics Act. He has urged the court to direct the government to initiate “criminal proceedings” against Mankind Pharma “and its agents” as a result. The high court has sought the reply of the ministry and Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory body, to the allegations raised in the application. The case will be heard next on August 5. As of March 27, The Indian Express’ own inquiries confirmed that some chemist shops in Delhi, Mumbai and Chennai were selling Longifene tablets and syrups belonging to batches manufactured before December 2018. These packages did not carry the mandated disclaimer, the stores did not stock any Longifene syrups manufactured during or after December and the pharmacists said Longifene can be used to increase appetite.
Ineffective enforcement by authorities
Several pharmacies continue to sell buclizine as an appetite stimulant months after the government banned the drug for this usage. Old stocks of the drug remain in the market without awareness labels. This implies ineffective surveillance and enforcement of the regulation by authorities, which could put patients in danger.
However, in one instance where a pharmacy was selling December 2018-manufactured Longifene tablets, the box containing the strips carried a sticker with the required disclaimer. The manufacturing, sale and distribution of drugs are primarily regulated by state licencing authorities, according to Drug Controller General of India Eswara Reddy. “State Licensing Authorities (SLAs) have the mandate to enforce statutory provisions. CDSCO zonal and sub-zonal offices are also being sensitised to take action in coordination with SLAs,” he told The Indian Express in response to queries.
Those found manufacturing, selling or distributing buclizine on or after December 13 without adhering to the government’s orders is liable for punishment under India’s drug regulations, according to him. This includes imprisonment for up to three years and a fine of up to Rs 5,000. Emailed queries to Mankind Pharma on March 26 and March 27 remained unanswered by press time Thursday. Mankind is the leader in India’s Rs 12.4 crore buclizine market, with nearly 35 lakh units sold in the 12 months ended February 2019, according to market research firm AIOCD Awacs PharmaTrac.
Thakur’s application is part of his ongoing lawsuit to ban certain medicines sold in India despite government experts having red-flagged them for safety issues since 2012.