What are your views on the penalty to Ranbaxy and do you believe the $500 million payout was too harsh?
It’s unfortunate. The company lost over $500 million in business opportunities, which may be the highest for any generic company, but the Food and Drug Administration (FDA) penalty has been higher for many global leaders, like GlaxoSmithKline (British) which signed a consent decree in 2005 to post a penal bond of $650 million for violation of manufacturing standards. In 2011, the FDA issued a consent decree to McNeil Consumer Healthcare, a Johnson & Johnson (US) subsidiary, over its repeated manufacturing problems (for drug Tylenol), indefinitely closing one plant and placing oversight over the two others. In another consent decree, Ben Venue Laboratories, a subsidiary of Boehringer Ingelheim (German), was restrained from manufacturing and distributing drugs from its Ohio facility until FDA determines that its operations are compliant with the Federal Food, Drug & Cosmetic Act. The loss of business and reputation is a greater risk than the penalty payable.
Does the closure of this case impact the Indian generic drug market?indian manufacturers
The consent decree puts a lid on the case. The company (Ranbaxy) can now start afresh and focus on its business. It is unlikely to have any spillover effect on other Indian companies. The US FDA processes are very objective and thorough, but unbiased. The fear of collateral damage is from the foreign competition. They may use this episode to contain the challenge of safe, affordable and quality generics from India.
What are the learnings Indian companies can take away from Ranbaxy’s issues with the FDA?
The first and most important lesson is not to compromise quality and safety of medicines. The second and more important lesson is not to cover up, even if the error is inadvertent. In this context, Johnson & Johnson’s response to owning up to the responsibility for manufacturing and quality defects in an over-thecounter drug Tylenol is noteworthy.
Has the case damaged the reputation of the Indian generic drug market, and Ranbaxy in particular? Will exports from other Indian companies gain from their disgrace?
One cannot rule out collateral damage by foreign competitors, but all Indian companies will have to work together to prevent such damage. After the consent decree, when the company (Ranbaxy) is able to resume supplies,indian manufacturer it is unlikely that other Indian companies can take away their business. Whatever was lost, was lost before the consent decree (was signed).
Falsification of data and violation of manufacturing process guidelines were charges leveled against Ranbaxy. Are those widespread problems in India?
Regulators from different jurisdictions have not come across such practices which confirm it is not a widespread problem.,indian suppliers
Cases of adulterated medicines have been reported from the Indian market as well. Why aren’t our norms as stringent as the FDA?
The National Drug Regulatory Authority is a product of the milieu. It evolves by national priority and is generally in conformity with the standards of general hygiene, sanitation and drinking water. India is moving towards improving these standards and has made significant progress in the last decade. However, we still have a long way to go. In the meantime, companies looking at the developed markets adopt appropriate standards to suit their business requirements.
In the US and other developed markets, there is a robust system of recalling all consumer goods, including medicines. What do we have in India?
Rules 54 and 55 of the Drugs & Cosmetics Act have provision for freezing and destroying stocks of sub-standard medicines. Rule 74(j) of the Act empowers the licensing authority and obliges the manufacturer to recall medicines not conforming to the standards.
Companies follow strict guidelines for the export of medicines. Why can’t they then abide by the same standards in their home market?
India does not have different standards for different markets. However, the manufacturers comply with the standards of the respective markets where they are selling their products. The h a r m o n i z at i o n o f standards is a major challenge. Political leadership and drug regulators need to work on it. Some progress is made under the ICH (Inter national Conference on Harmonization), but there is still a long way to go.