There are about 16 odd FDCs including Aloe Vera+Jojoba oil+Vitamin E, Aloe Vera+Orange Oil, Aloe Vera+Vitamin E+Herbal, Aloe Vera+Jojoba Oil+wheat germ oil+Tea Tree oil, among others, which are likely to be part of a list of products to be banned. The other FDCs which fall under the same category are Paracetamol + Lidocaine, acetyl salicylic acid+ethoheptazine used as pain relievers. They have been under the government scanner from 2021.
A FDC contains two or more active ingredients in a fixed dose ratio, but in India several FDCs are found to be irrational or are not scientifically validated for safety or efficacy through rigorous tests for patients.
Earlier in March 2023, companies producing such FDCs were asked to give a presentation, representing their case justifying the need for these products. The companies were asked to submit a summary with the “highest level of evidence,” supporting the claim of postulated advantage/rationale, along with the published data regarding safety and efficacy of FDC. They were asked to share whether these FDCs are marketed in the EU, UK, Canada, Australia, Japan and the US.
The companies were also told to mention country wise product names, ingredients, dosage forms, it’s strength, amount of usual ingredients per dosage form and the countries where the drug is marketed, approved, withdrawn, among other details.
“The companies were heard out and it was found that “there is no therapeutic justification” for these FDCs, and they may involve “risk” to human beings,” said a senior government official.”Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC”, another person said.They were earlier considered as “irrational” by a panel led by Chandrakant Kokate, vice-chancellor of KLE University in Karnataka. However, a sub-committee formed under the chairmanship of Nilima Kshirsagar, former dean of G.S. Medical College and KEM Hospital in Mumbai, was asked to examine and review the safety, efficacy and therapeutic justification of these drugs.
The sub-committee recommended “prohibition” of these FDCs, saying they could pose a risk to human beings.
Last month the report was submitted before India’s top technical body on drugs which agreed with the recommendations of the subcommittee. “The recommendations have now been sent to the health ministry for further action,” added the government official.
In India, the overall market for aloe vera combination is worth ₹90. 7 core and growing at 27% annually, PharmaTrac data shows.
