Phensedyl received DCGI approval in 1995 and has been in Indian market since the 1980s
A number of Indian and multi-national pharmaceutical companies on Tuesday got temporary relief from the Delhi High Court, which stayed a government order banning nearly 350 drugs on safety grounds. This was a day after Pfizer got a similar relief.
Abbott India, the local arm of American pharmaceutical multinational Abbott Healthcare, said that it had obtained an interim injunction suspending the operation of the government notification that prohibited the manufacture, sale and distribution of several fixed dose combinations already approved for use, till the next date of hearing.
“Abbott reviewed the Drug Controller General of India (DCGI) notification regarding fixed dose combinations and approached the Delhi High Court for relief, as we were not informed, consulted or allowed a representation by the authority for some important products,” a company spokesperson said in a statement.
The banned Phensedyl received DCGI approval in 1995 and had been on the market in India since the 1980s, the statement said, and claimed that the syrup had been used safely and effectively by physicians and patients alike.
“Some of the other formulations in our petition are in use globally, including the US, UK and Australia, and are approved by regulatory bodies such as the US FDA (Food and Drug Administration),” according to a statement issued by the company.
