The regulator has threatened to initiate criminal action against the company for marketing the product in India.
This is undoubtedly a bold move but DCGI's action borders on risking a review of the entire product licensing policy in India.
Here's why: Natco obtained the approval to market the product last year after submitting all the necessary clinical trial data on patients.
As is usually practiced, DCGI is assumed to have noted the comparative studies of Natco's drug with the standard product before issuing the marketing licence to Natco.
In order to come clear, a company takes all the necessary precautions before the submissions are made so that the approval comes without any reviews or pre-conditions.
The question is why the product was not seen as "sub-standard" at that point in time before the approvals were granted.
If DCGI now says the product is sub-standard since there are differences in data and the actual product, as media reports suggest, did any of the patients on Natco's Albupax report adverse reactions following the launch?
Natco's product is a clone of Abraxis' flagship brand Abraxane and is delivered to the breast cancer tissue using the nanotechnology bound in albumin.
Having a comparatively high rate of solubility, albumin is an excellent delivery vehicle and reaches the active ingredient to the tissue, thereby providing better results compared with other drugs.
This is a difficult technology and one of the few cases where nanotechnology is combined for effective cancer therapy.
The approval process of the regulator, therefore, is expected to be more stringent than an average chemistry-based product.
Drugs in future will be more and more complex. It is very important therefore that the Indian government overhauls its regulatory machinery to be able to examine the products through the right test methods.
Natco has gone on the defensive in the present case.
In a public notice to investors, it has denied any legal action from DCGI and at the same time blamed rivals for resorting to an insidious campaign with an aim to malign its image and reputation.
To those who know, Biocon has been licensed by Abraxis to market Abraxane in India and Natco is taking a direct dig at the Bangalore-based company.
Natco has clarified that the test results on endotoxin levels are highly dependent on the test kits employed primarily due to the interference caused by the nano-particulates and excipient proteins.
As per Natco's interpretation, the Charles River kit employed by the government's Central Drug Laboratory is known to vary as much as 2 to 4 times according to the manufacturer's (innovator) own manual.
Natco, on the other hand, uses Lonza's kit which gives different set of results and those are accredited by the desired agencies.
This leaves a lot of questions to be answered.
If Natco is right in its claims, how does the government conclude on the authenticity of the two test results? It will be very crucial for the government to standardise the process and work on approval processes that are unambiguous.
Natco has heightened the controversy by blaming rivals.
Corporate fights are common in every sector but can the official machinery be manipulated to attack another company?
There has been no clear evidence yet and so it may be improper for Natco to pin the blame on another company.
DCGI should ideally substantiate its actions on such critical issue through its own official communication lines than feeding information through newspapers.
The US Food and Drug Administration transparently put every record straight on its websites so that everyone gets clarity.
Threats of taking drug companies to court are not the best way to encourage regulatory compliance.
At a time when noises are being made for harmonisation of regulations with the developed markets, DCGI can do better by streamlining its testing activities and getting geared up for more complicated product examinations.