Some examples of these “new drugs” containing nutraceuticals involved the combinations of probiotics and antibiotics, as well as the combination of omega-3, botanicals and minerals.
In India, “new drugs” or “fixed dose combination” drugs contain one or more active ingredients used for a particular indication(s).
They have to be evaluated for safety and efficacy according to the New Drugs and Clinical Trials (NDCT) Rules 2019 and have to obtain approval from the Drugs Controller General India (DCGI) before they can be manufactured, sold, and distributed.
The Central Drugs Standard Control Organisation (CDSCO) recently put up a notice of “new drugs” where their licenses have been cancelled or voluntarily surrendered by the manufacturers themselves, as they did not obtain approval from the DCGI.
A total of 35 unapproved “new drugs” were published. Of which, at least eight contained nutraceutical ingredients like co-enzyme Q10, lactic acid bacillus, and vitamin D.
Irrational combination?
Industry experts that NutraIngredients-Asia has spoken with said that aside from failing to obtain prior approval, some of these nutraceutical formulations also lacked rationality.
An example is item number eight on the notice published by the CDSCO.
It is a tablet containing the antibiotics cefixime at 200mg, ofloxacin at 200mg, and lactic acid bacillus at 60 million spores.
Dr. Vaibhav Kulkarni, founder and director Zantus Lifesciences and the honorary secretary of India’s Health Foods and Dietary Supplements Association (HADSA), said that this was an example of a formulation that lacked rationality.
“This, I feel, is a little bit of an irrational combination because how can there be two antibiotic be paired with lactic acid bacillus?” he said.
Even if the manufacturers are of the view that these combinations could work, they should first obtain approval from the CDSCO.
“If you feel that these combinations really work, then there is a New Drugs and Clinical Trials (NDCT) guideline which was published in 2019.
“Because this [formulation] is a new fixed dose combination, this is actually considered as a new drug.
“And so, it is treated as a new drug and for that, you will have to follow all the steps that is required for the new drug approval,” he said.
He added that manufacturers of “new drugs” should proactively check if any of their existing list of “new drugs” had obtained license from authorities none other than the CDSCO.
One of the reasons that these “new drugs” have been circulating in the market is because they had obtained approval from the State Licencing Authority (SLA), when they should be approved by the CDSCO in the first place.
The CDSCO, in its notice, said this has shown a lack of uniform enforcement of regulations, and multiple letters have been issued to the SLAs on this matter.
It added that obtaining their prior approval is required, as these “new drugs” would need to go through safety and efficacy evaluation based on NDCT rules 2019.
“The approval of such unapproved FDCs [fixed dose combinations] compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation.
“Upon issuance of show cause notices to the manufacturers, they have stated that these licenses were granted by the respective Drug Licensing Authorities and have not violated any Rules.
“This has resulted in a lack of uniform enforcement of the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940 across the country,” said the CDSCO.
In the same vein, Dr. Vaibhav has urged manufacturers of “new drugs” to go through the proper route of obtaining prior approval from the CDSCO.
He added that the SLAs should have directed the manufacturers in obtaining approvals from the CDSCO as well.
The ban on the unapproved “new drugs” currently circulating on the market would also mean that these products would no longer be available for doctor’s prescription.
In this case, Dr. Vaibhav said that there should be alternatives available for doctor’s prescription and proper explanations be given to patients on the events that have transpired, as well as potential health risks of consuming the unapproved “new drugs”.
Pradip Chakraborty, former director at FSSAI also advised that manufacturers that wished to continue producing these not yet approved “new drugs” should also go through clinical trials first.
“Since safety and efficacy are in doubt for these products, the drug manufacturers will actually have to do clinical trials,” he said, adding that the CDSCO will then examine the trial findings.
Reformulation an alternative
Another way forward is to reformulate the not-yet- approved “new drugs” into nutraceuticals, Chakraborty advised.
In the meantime, the manufacturers could send their not-yet-approved “new drugs” for clinical trials and submit the results to the CDSCO for evaluation and approval.
“Since safety and efficacy are in doubt for these products, the drug manufacturers will actually have to do clinical trials,” he said.
“My suggestion to the companies is that they should go for clinical trials and reformulate the products simultaneously.
“This is because some of these product brands may be reputable in the market and companies would not want these brands to be wiped out from the market.”
