Patna: The drug control administration has sent out notices to around 400 pharmaceutical companies for using green dots on packs of gelatin-based capsules.

The Muzaffarpur-based drug inspector, Vikas Shiromani, on Thursday said many medicines were found with gelatin encapsulation but they had green mark on their packaging. Norms stipulate that medicines with gelatin encapsulation should have red dot on their cover, as gelatin is obtained by processing connective tissues, bones and skins of animals.

Shiromani said apart from sending notices to pharmaceutical companies, separate mails had also been sent to the Food Safety and Standards Authority of India (FSSAI)'s Delhi office and the Drug Controller General of India (DCGI) in the first week of September.

"Medicines with cellulose encapsulation should only have green dot on the cover, as it does not involve non-vegetarian products," he said.

"The pharmaceutical companies have got FSSAI certification, as the drug cover mentioned about it. The drug cover also clearly mentions that the capsule cover is made with hard gelatin. Despite the fact, the medicine covers are found with green dot. How could the FSSAI allow this when it provides those certification? We have sought a reply on this besides informing the DCGI and have sought proper action on this. The state drug controller and the food safety commissioner have also been informed about this matter," said Shiromani.

"The pharmaceutical companies have been found violating sections 3 (b), 18 (A) and 18 (B) of the Drug Cosmetics Act, 1940. "In case we don't get satisfactory reply from the drug companies, FIRs might be lodged against them later," he added.

It is worth mentioning that gelatin is not only used for encapsulation of drugs but is also used by the processed food industry. Sources said majority of drugs have gelatin-based encapsulation and very few have cellulose encapsulation. Drug manufacturers willingly invest in gelatin because the cost of drug goes up with cellulose encapsulation.