India’s apex drug regulatory body Central Drugs Standard Control Organisation (CDSCO) has issued an advisory to state drug regulators, telling them to “keep a strong vigil” on the manufacture, sale and distribution of a brand of antihistamine and motion sickness medicine buclizine, The Indian Express has learnt.
The move comes after it was found that a government order three months ago prohibiting the sale of buclizine as an appetite stimulant has not been followed and several batches of the drug continue to be sold without mandated disclaimers.
The Health Ministry had issued an order in December 2018, stating that the use of buclizine as an appetite stimulant was “likely to involve risk” to human beings. It had 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”.
“It has been brought to the notice of this office that Longifene … tablets and syrups continue to be sold in pharmacies without complying with the above labelling requirements,” stated Drug Controller General of India Eswara Reddy in a fresh advisory by the CDSCO. Reddy is the head of CDSCO.
“In view of the above, you are requested to direct your inspectorate officials to keep a strong vigil on manufacture, sale and distribution of buclizine and its formulations for use in human beings and in case of contravention of any provision of the said Act (Drugs and Cosmetics Act, 1940) and Rules made thereunder, and take necessary action to ensure that the drug is manufactured, sold and distributed strictly in accordance with the provisions of the said Act and Rules,” the advisory added.
CDSCO has also asked its own zonal and sub-zonal offices to “take similar action” in coordination with state licencing authorities. The Indian Express has reviewed a copy of this advisory.
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, Reddy had earlier said. This includes imprisonment for up to three years and a fine of up to Rs 5,000. Queries sent to Mankind Pharma about this development remained unanswered by press time Friday.
The Indian Express on March 28 reported that a private investigator’s survey of over 170 pharmacies in Delhi, Gurgaon and Hyderabad showed that Longifene, Mankind Pharma’s buclizine brand, continues to be sold for appetite stimulation without the required label. This had caused public health activist Dinesh Thakur to approach the Delhi High Court last week urging that the government be directed to initiate “criminal proceedings” against Mankind Pharma and its “agents” for not recalling Longifene batches manufactured before December 2018, which did not carry the labels.
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. It adds that the government has not even furnished a copy of the report or findings of an expert committee constituted in March 2013 to “investigate” the manner in which the approval for buclizine as an appetite stimulant was given.