Today, pharma companies from India are no longer minnows in the global pond, but there are obviously bigger fish fiercely guarding their turf. Pharma MNCs have their own existential problems. A GlobalData study predicts that they will suffer an estimated $65 billion drop in sales by 2019 due to patent expiries of several leading drugs.
Besides turf wars with pharma peers, global regulators too are ratcheting up their benchmarks. They are more connected to each today than in yesteryears, with regular sharing of information and results from inspections. And action by one automatically puts a company on the watch list of the others. Take the most recent case of Hyderbad-based CRO GVK BIO being accused of “serious and systematic deficiencies” in the bio-equivalence (BE) studies it conducted for companies in the EU markets.
EMA’s Committee for Medicinal Products for Human Use (CHMP) found that GVK BIO’s BE studies conducted at its Hyderabad clinical development facility since 2008-2014 were not sufficient to support Marketing Authorization Holders (MAHs). The EMA cited a previous inspection by the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), France’s National Security Agency of Medicines and Health Products, which had concluded that some GVK BIO employees had taken print outs of ECGs from one volunteer and used them for other volunteers. Even though GVK BIO got reports from four cardiologists which indicated that the check-out ECGs could belong to multiple volunteers and it was difficult to conclude that they belonged to the same volunteer, the French inspector concluded that the studies did not meet the Good Clinical Practices (GCP) guidelines and should be rejected.
The EMA’s CHMP’s reasoning was that since some of the same employees involved in check-out ECGs could be involved in other critical activities, it left an element of doubt on the BE results. Germany’s regulator, The Federal Institute for Drugs and Medical Devices, soon followed suit after its own investigations.
GVK BIO insists that it was a matter of interpretation and points out that check-out ECGs are conducted before volunteers leave the clinic merely as an additional safety test, and do not form part of any international clinical trial guidelines. The statement leads one to believe that the check-out ECGs were an additional precaution taken by GVK BIO to ensure that volunteers are safe on key health parameters before leaving the site and were not taken as a drug efficacy parameter, and may have no direct relevance to the quality of the testing of drugs.
The CRO also quotes from the ANSM’s website where it has been stated that the decision was taken as a precaution and no element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs. It has agreed to redo the trials but stands by its protocols. Of the nine studies randomly chosen for a review by the French inspector, not all required ECG monitoring, but according to a GVK BIO spokesperson, check-out ECGs are done on all its volunteers, as matter of its internal protocols.
What is eminently clear from this chain of events is that global regulators will not tolerate even a shadow of doubt when it comes to safeguarding the health of their citizens. Clearly, this is a continuation of the backlash from a rash of GMP violations, which were first denied or covered up. What it also means is that pharma companies (and CROs for that matter) from India will have to ensure that their protocols measure up to global standards and scrutiny. And that each employee follows the protocol to the T. Pharma companies are waking up to the need to engage proactively with employees. (See story: Engaging the new age employee, pages 46-50).
Winning back the trust of global regulators will be tougher and GVK BIO’s experience will no doubt have lessons for all of us.