The Bulk Drugs Manufacturers Association (BDMA) has represented to the Union Government against its proposed move to exempt the import of drugs under the Advanced Licence Scheme. In a memorandum submitted to Union Minister for Health and Family Welfare Sushma Swaraj, the BDMA argued that any concessions granted for import of drugs without registration would defeat the objective of the legislation. The memorandum highlighted the need for import registration even for those drugs that are imported under ALS, both bulk and formulations.

According to Venkat Jasti, president, BDMA, “If drugs were imported without registration, then it would defeat the objective of the new legislation that talks about giving a level-playing field for Indian manufacturers and manufacturers outside India in respect of their exports to our country.”

BDMA made the representation following reports that the Director-General of Foreign Trade (DGFT) was planning to exempt import registration for those drugs that were imported under ALS for the purpose of export. Venkat Jasti said such a move would create a situation so that two different qualities of drugs would be available in the market, one from a registered source and another from non-registered source and used for local consumption.

BDMA was of the view that it would not give a level-playing field in the domestic industry with the foreign manufacturers. It would also damage the reputation of the country on quality parameters in the global scenario. “The move would adversely affect the image of the country as the drugs are consumed by humans and it does not matter if they are Indians or foreigners,” Venkat Jasti said.

“Besides, the imported drug ingredients may not have regulatory control at par with Indian regulations. China, for instance, does not have regulatory control at par with the Indian Drugs and Cosmetics Act,” he said.

The memorandum said the export of formulations under ALS, as compared to the total export of formulations under various other schemes, were not even, if one were to consider this as loss of business.