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As the gridlock in Washington subsides for the time-being, the effects of the Patient Protection and Affordable Care Act; so-called ‘Obamacare’ are set to extend to all corners of the globe.
Obamacare looks set to trigger a shift in the balance of power in the global pharmaceutical industry. We review the news to identify the key issues for Quality and Compliance Teams within Pharma-chem companies.
$350b Bonanza for Indian and Chinese Pharma
The introduction of the new legislation will inevitably lead American purchasers to source generic drugs at a reduced cost. Indian and Chinese generic manufacturers are gearing up for a bonanza that will see them try to prise away market share in the $350 billion US market.
The major challenge for the Indian and Chinese manufacturers will be compliance with exacting FDA regulations and the introduction of compliant manufacturing processes and record keeping essential to deliver the product quality expected by the American market.
FDA Sanctions in 2013
Already this year, according to agency data, as many as 19 manufacturing facilities in India have been barred by the FDA from supplying products to the US, more than any other country. Problems faced by Ranbaxy Laboratories, Wockhardt, RPG Life Sciences and Dabur India have been widely publicised and here. Chinese Pharmaceutical facilities have received the next highest number of sanctions at seven.
Indian and Chinese companies will need to accept intense scrutiny if they want to make the most of the opportunity. India is one of the first countries, apart from China, in which the FDA has opened offices, and the country recently allowed the regulator to increase its number of inspectors in the country by seven to 19.
The US and European pharmaceutical giants will no doubt look to protect their position but this is likely to lead to cost-cutting and pressure on the ability to deliver quality at the right price.
This dilemma of a squeeze in resources and a demand for greater efficiency will force Quality Managers and Compliance Teams to review their processes, adopt new technological approaches all under the burden of greater over-sight.
Ultimately, the consumer is set to benefit provided the FDA and other regulators retain the power and sanctions needed to assure their protection.
Robert Oakley, Qualsys Director said:
"At Qualsys, we are already seeing a greater demand for iEQMS Auditor for mobile auditing, ECMS Change Management software and EQMS Risk Manager - all tools with powerful workflows that can easily demonstrate business efficiencies and ROI.
EQMS interest from Pharmaceutical Manufacturers in China, the Middle East and the US, shows us that everyone sees the same opportunity and feels the same pressures.
It will be interesting to see how Obamacare plays out."