Indian pharma industry needs to synchronize its regulatory compliance for both domestic and international markets. The only way to achieve this is to create competent human resources who comprehend the criticality of uniform compliances, said Dr Rao Vadlamudi, president, Indian Pharmaceutical Association.

The industry should not separate quality norms for drugs manufactured for exports and local markets. The key reason for the current regulatory challenges faced by Indian pharma is that it is not being able to sustain the quality standards because of capability issues. IPA will take a lead in forming focussed groups and subject the human resources to external training and create Centres of Excellence in academic institutions. Since IPA is already collaborating with global bodies like the ISPE and DIA, it could chip in assistance to help industry maximise its human resources talent, said Dr Vadlamudi.

In his key note address on ‘Developing Capabilities to meet the Current Challenges’ at the IPA-Karnataka seminar, held here in Bengaluru, he appreciated that India is 4th largest pharmaceutical market in volume and 14th in terms of value. The US pharma market is valued at $240 billion of which 50 per cent accounted for generic drugs and India exported 25 per cent of this to the region.

“While we do have the capability to produce quality drugs meeting stringent global regulatory standards, sustaining this capability is a task. When Indian pharma could produce drugs to meet the unmet clinical needs of its patients in the country, there is need to align its regulatory compliance efforts on similar lines that of its global efforts. This is the only way to manufacture uniform quality drugs,” he said.

In order to ensure consistency in manufacturing, there is need for proficient  human resources. Pharma manufacturing is driven by innovation, state-of-the-art technology and regulatory compliance. Now to survive in a competitive environment, it is vital to update and sustain core capabilities. This is because the capability to perform manufacturing operations are an outcome of suitable equipment and technology installed in the pharma production facility which needs to be backed by persons armed with the know-how. The advanced infrastructure combined with qualified-trained manpower helps to fulfill global regulatory challenges, said Dr Vadlamudi.

It is also equally important to ensure that a well established pharma facility is frequently subjected to internal and external audits only to make certain that standard operating procedures are in place. Again here, only skilled personnel could ensure optimal efficiency of plant and machinery, he said.

Indian pharma should conduct in-house and external training programmes to keep pace with the transformations. Even after this, the industry is faced with an even bigger challenge which is to retain the trained workforce. Now pharmacy education in India is designed to create the required competence to drive quality and efficiency. However, the need of the hour is to synchronise regulatory compliances for exports & domestic markets, stated Dr Vadlamudi.