Multinational pharmaceutical companies engaged in clinical trials are increasingly becoming wary of the inordinate delays they are facing in getting regulatory approvals in the country.
The representatives of global pharma firms complain that their applications, which are part of the multi centric clinical trials being planned by such firms across the world, are stuck in the office of the Drugs Controller General of India (DCGI) for several months now.
Foreign drug multinationals, Pfizer, Novartis, Bayer, GlaxoSmithKline, Sanofi Aventis, BMS to name a few, are all part of clinical research — pegged at a current size of $400 million (Rs 2,000 crore) — in India.
Official records show that the number of global clinical trials has been remaining stable at about 250 approvals a year for the last three years. “This is likely to decline this year if approvals are delayed inordinately,” company representatives said.
The company officials, who did not want to be identified, said that in some cases where applications are pending for more than six months, the global firms have been compelled to call off their clinical trials in the country and proceed elsewhere.
For instance, what troubles one of the leading European drug multinationals is the long delay in obtaining a licence to import the experimental drug — which has an approval for clinical trial in India — from its parent unit.
Company officials say that such delays are not only harming the industry interests, but also putting the patient undergoing the trial under increased risk.
Despite repeated attempts, DCGI was unavailable for comments. However, a senior health ministry official acknowledged the delay and attributed it to the increasing workload of the drug regulator.
In most cases, company representatives complain, the applications are pending because of a string of queries raised by the regulator. “One can understand queries being raised over the applications filed by new players. But how could one explain if even experienced ones are getting query after query though several of them could be considered as non-essential?” asks Arun Bhatt, president, Indian Society for Clinical Research.
According to Bhatt, the general complaint among clinical research industry — including contract research organisations (CRO) which he represents — is that the approvals are pending up to nine months now.
Interestingly, the office of DCGI has declared a time line of 45 days for approval of clinical trials.
The company officials say the time line has no meaning because it stops whenever a query is made. “Of the reasons for the delay, about 40 per cent are query letters. If the current timeline is unrealistic, let us them make it longer. But certainty of approvals is critical in this business,” Bhatt said.
While global drug firms have the option to shift their trials to other countries, domestic CROs are solely dependent on the clinical trial contracts they sign with such companies.