The above headline is in no way intended to mean that this discussion is on spurious or counterfeit drugs.
Today’s deliberation is on the licensed drugs, which are manufactured in India, for the patients of the country, by the manufacturers holding valid drug licenses from the Indian regulators.
Close on the heels of my article titled, “USFDA ‘Import Bans’: The Malady Calls For Strong Bitter Pills “, another equally serious incident related to drug safety, came to the fore.
Fabricated data from the Contract Manufacturer of large companies:
On November 12, 2013, the Drug Controller General of India (DCGI) was quoted saying that the investigative team of the drug regulator concluded that all the data submitted by Puducherry-based contract drug manufacturer GuruFcure, while seeking approval for manufacturing seven fixed dose combination drugs, are ‘fabricated’ and not ‘authentic’.
GuruFcure, which started operations in 2007 and calls itself “one of the leading pharmaceutical formulation manufacturers in India”, reportedly manufacture drugs for the leading pharma MNC and Indian companies and Indian companies such as:
- Abbott
- Alkem
- Glenmark
- Wockhardt
- Unichem
- Intas Pharma, among others.
Though, as per media report, Wockhardt and Glenmark said that these two companies are not currently associated with GuruFcure, the fact remains that they did market drugs produced by this contract manufacture in the past and the patients consumed those drugs against doctors’ precriptions.
Large players need to set examples:
The largest pharmaceutical company in India with highest share of the Indian Pharmaceutical Market – Abbott, has also been reported to get some of their drugs manufactured by this contract manufacturer.
Not a solitary example:
Just prior to this incident, in November 8, 2013, the DCGI reportedly ordered the Indian pharma major Sun Pharmaceuticals to suspend clinical research activities at its Mumbai based bio-analytical laboratory, after discovering that the company does not have the requisite approval from the central government for operating the laboratory. The DCGI has decided not to accept future applications and will not process existing new drug filings that Sun Pharma has made from the Mumbai laboratory until the company gets an approval.
Tardy regulatory system fuels apprehensions:
In India, many large, medium and small units get their products from the contract drug manufacturers. As compared to the USFDA inspection data, there are virtually no public data available on the details of inspections carried out at these plants by the drug regulators indicating the level of cGMP compliance.
Health being a state subject in India, State Drug Controllers should play a critical role in ensuring drug safety for patients through regular inspection of these manufacturing facilities on cGMP compliance.
Conclusion:
If cGMP violations can take place for drug exports, despite rigorous compliance checks by the foreign drug regulators, what could possibly happen when the same system is so tardy in India?
While the MNCs boast on their highest drug regulatory compliance standards, even for contract manufacturers, why do they keep relationships with those getting caught for fraudulent practices, is equally difficult to fathom.
One may possibly describe such incidents as just aberrations. However, that conclusion can only be drawn, when we have Drug Controllers’ cGMP inspection data for a large number of drug manufacturing units in India with details. Unfortunately, that is not the case, in any way.
In such an environment in India, the moot question that comes at the top of mind, “Are we taking safe and effective drugs, whenever required?”
By: Tapan J. Ray
Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.