Licences of 10 Liposomal Amphotericin B Injection Makers Suspended

New Delhi : The manufacturing licences of 10 drug manufacturers in six states have been suspended, the government informed the Rajya Sabha.

"The Central Drugs Standard Control Organisation (CDSCO) asked the State Licencing authorities concerned to suspend the manufacturing licences of 10 manufacturers of Liposomal Amphotericin B Injection on March 11, 2016," the Minister of State for Health and Family Welfare Shripad Yesso Naik said during Question Hour.

He said the injection is used for treatment of systemic fungal infections and for Vesceral Leishmaniasis (Kala Azar) and the manufacturing licences of such drug makers have been stopped after an expert group of ICMR made recommendations to this effect.

The Committee had also recommended that Liposomal Amphotericin injection marketed in India may be regulated under Section 26A of the Drugs and Cosmetics Act, 1940 and the manufacturers of the injection were asked to prove the quality, safety and efficacy of their products on the basis of scientific criteria suggested by Expert Committee.

"We have not terminated their licence, but have asked the manufacturers to fulfil the conditions and then will restore their production. Directions have also been given to states to suspend licences of all such medicines till they fulfil the conditions," the Minister said.

"Show cause notices were issued to all 10 manufacturers to reply within 3 weeks as to why the manufacturing licences issued to them for their products Liposomal Amphotericin injection should not be suspended.

"Out of 10 manufacturers, 7 responded and it was found that their responses were not satisfactory to conclude that the products are safe and efficacious. Accordingly, state licencing authorities were requested to suspend manufacturing licences of all the ten manufacturers of the product in public interest," he said in his written reply.

Asked how many states have implemented the orders, Naik said, out of six states, five states have suspended the licences as directed by the Expert Committee, while the report from Gujarat is yet to come.

To a question on whether such medicines banned were being sold through CGHS dispensaries, the Minister said he will seek a report and asked the member if he had some information to share for action to be taken.

In reply to another question on implementation of Cigarettes and other Tobacco Products Act (COP TA) prohibiting the sale/advertisements of smokeless products within 100 yards of schools, the Minister said states are implementing the law.

"12 states, excluding Lakshwadeep, have implemented the law for displaying tobacco warnings on their products and states are implementing the law," he said.

On surreptitious advertisements on chewing tobacco in TV, the Minister said the Centre will help implement the law properly.