The withdrawal of anti-retroviral AIDS drugs manufactured by three Indian pharmaceutical companies -- Ranbaxy, Cipla, and Hetero -- from the list of such drugs approved by World Health Organisation for treatment in poor African countries has sent shock waves through Indian contract research orgnisations.
They were the ones that did the bio-equivalence studies needed to affirm that a generic copy of a patented product has all the chemical and therapeutic properties that the original has, and it is their studies, which have been faulted.
Since the drugs in question are ultimately the properties of the pharma companies, the face of the Indian pharmaceutical industry has also been sullied.
This is particularly because one of the transgressors is perhaps the most respected name in Indian pharma, Ranbaxy. The feeling currently running through the Indian pharma and CRO industries is: How could, of all people, Ranbaxy slip up in this manner, more so when it has its own elaborate setup to conduct such trials?
What is more, Cipla has been at the forefront of the campaign to make cheap generics available to save lives, against the opposition of the drug majors. Surely, Cipla owes everyone as explanation.
Industry sources are particularly perplexed as to why the companies in question did not withdraw their drugs before the WHO audit of the CROs concerned because they must have known that these bio-equivalence studies had no chance of passing muster.
WHO first gives pre-approval to a drug on looking at the information dossier submitted for the drug, on the basis of which a company can start marketing its product. The audit of the CRO covers examinations of its documentation, processes, and facilities, and comes later.
The big question is: How did this happen, particularly when for decades now Indian drug companies have been able to effectively penetrate developed country markets, which have the highest regulatory standards, with their generic bulk drugs and formulations?
Through this they have been able to position India as an emerging global competitor in pharma. Indian industry watchers cannot recall any instance of such foul-up with developed country regulators.
The answer is that there are two standards in India -- one for developed country regulators and the other for the Indian regulator. The impact of this runs right through the entire Indian pharmaceuticals industry. The quality of drugs available in India ranges from the highest to the other end.
Naturally, the top end is occupied by those firms that are operating in the developed markets and meeting the highest standards of their regulators day in and day out, including having their Indian manufacturing facilities approved by the FDA and others. The same holds true of Indian CROs. Those that cater for developed country markets are a class apart.
Industry sources say that the genesis of the current problem lies in the fact that initially the Indian pharma companies and CROs in question considered WHO to be in the same category as the Indian regulator.
The studies which have been faulted were conducted a couple of years ago when the lie of the land was not very clear and WHO itself was in a hurry to get the cheap drugs to the market to begin the fight against the rampaging epidemic.
A word-of-mouth blame game is now going on between the CROs and the drug companies. The latter are saying that it is the CROs, which botched things up through their lack of rigour and standards.
This is true but the CROs are agents of the drug companies. There is no way a CRO can get away with slipshod work if the drug company client is very demanding.
In the course of earlier research I have myself come across an instance where a drug company (one of the three mentioned above) asked the CRO being entrusted with the work, intended for submission to the Indian regulator, to get ahead and finish it fast. The CRO refused to compromise on its own procedures and was prepared to lose the contract. As it happens, that CRO today has only developed country clients.
The buck must stop with the Indian regulator -- the drug controller general of India. Schedule Y, which among other things covers clinical trials, has been amended and good clinical practices have been laid down.
But the key point is that there is no supervision, no cracking the whip on defaulters, no audits. The authorities have been holding discussions with the industry but that's it. Is it any wonder then that at the end of the day the Indian market is flooded with sub-standard drugs?
Those who have the means to pay for quality and the necessary education insist that the pharmacy supplies not necessarily the brand the doctor has prescribed but the same molecule manufactured by a pharma company he can trust.
At the end of the day, the Indian citizen has to ask what kind of regulation he is giving himself. NGOs with the necessary intellectual equipment have to raise the level of public awareness over the standards and practices of Indian regulators.
It is necessary to point out that WHO is not on the side of the demons but has been fighting alongside Indian pharma interests to bring affordable life-saving drugs to the world's poor to help fight an epidemic.
The best Indian companies have the intellectual and manufacturing capabilities to bring succour to the afflicted. It is tragic that the bad influence of poor domestic standards has blotted the Indian drug industry's copybook and severely set back the CRO industry. The redeeming feature is that there will now be a shakeout in the CRO industry.
Indian drug companies like Dr Reddy's and Ranbaxy made a name for themselves globally by delivering top-class quality at competitive costs.It is the same story with Indian IT, demonstrated by its obsessive pursuit of quality certifications like SEI-CMM. The low cost of Indian knowledge workers has made India a natural choice for outsourcing of clinical trials. It is unbelievable that an industry should slip up and risk such opportunity.