The WHO decision last week to drop three of Ranbaxy's anti AIDS drugs from its pre qualification list is the second shock to the Indian pharmaceutical industry within a span of two months. The first was when WHO announced a similar decision to withdraw pre qualification granted to two of Cipla's anti retroviral drugs in May. Soon after this announcement, Medicines Sans Frontiers (MSF) decided to put on hold the supply of Cipla's drugs for the anti AIDS programme. WHO had made clear in both cases that decision was taken after data verification of the bio equivalence studies conducted by the respective contract research organizations of these companies. WHO had found certain anomalies in data handling and non-compliance with good clinical and laboratory practices relating to bio equivalence studies in the cases of both the companies. Responding to WHO decision, Ranbaxy stated in a press release that it has already undertaken work on new bioequivalence studies on the three products. The company also said that it has suspended all outsourcing work with the CRO, which did its studies. The WHO action against India's two highly respected pharmaceutical companies has even shaken the officials in the Union health ministry. They have reacted by saying that these anti AIDS drugs, manufactured by both the companies, have been approved by the DCGI and they meet India's required standards. The officials further said that WHO is also the procurement agency for India's anti AIDS programme and the Union government would insist on Indian drugs being procured for it.

Ranbaxy's reaction to the WHO decision brings forth certain critical issues involving pharma companies and CROs. Ranbaxy is not apparently satisfied with the work done by the CRO in the case of three anti AIDS drugs. That's why the company said in a statement that it suspended all outsourcing work with this CRO. Ranbaxy should have taken adequate care in selecting its CRO considering its tremendous exposure to international business. WHO action has indeed caused a lot embarrassment to the clinical research organisations in general in the country. That should be prompting them to tighten their documentation procedures and other operating systems. At the same time they point out that clinical research is a joint programme of the sponsor and the CRO and the CRO is doing what it has been told to do by the sponsor company. They have a point here and it is wrong to place the entire blame on CROs in cases like this. The sponsor companies should monitor the programme and ensure quality compliance at every stage. Another complaint of CROs is about the pressure the companies put on them to finish the trials within a very short time. Quality of clinical research work will certainly get affected under such pressure. It is important, therefore, for both CROs and sponsor companies to build up a right understanding between themselves for their own benefit and also to avoid a bad name for the country's pharmaceutical industry in the international market.