Johnson & Johnson has sought an extension of two weeks from the existing deadline of March 31 for filing reply to the notice of Maharashtra FDA, which questioned J&J over the use of liquid paraffin in its 'baby oil.'

According to FDA, although liquid paraffin is not harmful for adults, it could cause skin rashes, when applied on babies, and could be even carcinogenic as demonstrated in its studies.

According to sources, the Maharashtra FDA has therefore sought J&J either, to replace 'liquid paraffin' as ingredient in its products like baby oil and shampoo, or pull out descriptions like the word 'baby' or the picture of the child from the packs, making them more general and less exclusive in nature.

When contacted, Maharashtra FDA Commissioner A Ramakrishnan, said, "J&J officials have shown positive intentions of sorting the matter, but have sought an extension of two weeks to file their reply, which we have agreed upon."

As Maharashtra FDA cannot authorise the other state FDAs, it has sought DCGI intervention to redress this issue on a national level. The J&J is also said to be talking to the DCGI.

"Right now a three way communication is taking place between Maharashtra FDA, J&J and the DCGI," said Ramakrishnan.

Ramakrishnan said the use of liquid paraffin in baby oil violates section 17 C (c) of the Drugs and Cosmetic Act (1940) amounting to misbranding and misleading labelling.

An official spokesperson of J&J said the company has sent an "interim response" to the Maharashtra FDA in reply to its show-cause notice, seeking extra time to address all concerns. The company has been granted 15 days' time to file a final response. It is in dialogue with the FDA on the issue of branding and labelling, he said.