Cheaper generics making regulators more stringent

Regulators across the globe have opted for stricter norms to ensure quality of medicines

Even as Indian drug makers are looking for ways to wriggle out of the tightening regulatory noose of the US Food and Drug Administration (FDA), pharmaceutical companies have started facing a stringent environment in many other international markets.

With the rising reach of low-cost generic medicines, regulators across the globe have opted for stricter norms to focus on quality. For instance, regulators in emerging markets such as Brazil, Mexico, Russia and South Africa have changed various norms and guidelines for allowing the sale of generic medicines in their respective markets. This is leading to considerable delays in approval processes, as well as launch of medicines in these markets, say industry officials.

Recently, ANVISA, the national health surveillance agency of Brazil, considered one of the most efficient in emerging markets, changed its approval process to include bioequivalence testing. Industry officials say this has increased the product approval time in Brazil from about 36 months to 48 months. Companies such as Glenmark, Torrent and Cadila Health, which had significant presence in Brazil, were witnessing major delays in product approvals, the officials added.

“In fact, no new product approval has been granted by ANVISA in the past 18 months. The product registration process has also become extremely slow,” an official said.

The Brazilian pharmaceutical market in terms of revenue is the seventh-largest in the world and the largest in Latin America. Following the introduction of the new patent law in 1997, various multinational companies entered Brazil with their patented products. Now, generic reach is increasing consistently, owing to policy support from the government. However, industry officials claim of late, pressure on ANVISA to closely monitor generic medicines is up, as more applications come.

In Russia, another major emerging pharmaceutical market, primarily for Indian firms, the new regulatory directive mandates clinical trials for generic products, too. “Conducting a clinical trial for a generic is time-consuming and there are various regulatory processes involved. The new directive has created huge hurdles for players like us,” said an official from a domestic company operating in Russia. “We are not expecting any new product approval in Russia this financial year because of this regulatory change,” said a Glenmark official. Currently, the company is conducting six-seven clinical trials in Russia.

In the US, companies, including Ranbaxy and Wockhardt, have recently faced enforcements for faltering on regulatory compliances and manufacturing practices. Wockhardt is also facing action in Europe, another major pharmaceutical market. Experts, however, say the tightening norms and procedures aren’t specific to Indian drug makers. “Indian companies have a significant foothold and governments across the globe are becoming more conscious to ensure quality medicines for their patients,” says ChrysCapital Managing Director Sanjiv D Kaul, who has worked with various pharmaceutical companies, including Ranbaxy.

Not just in foreign markets, domestic makers are facing tighter scrutiny at home, too. Recently, the domestic drug regulator, Drugs Controller General of India, had constituted several new drug advisory committees to oversee clinical trials, new drug approval processes, etc. Industry officials complain strict monitoring by the Supreme Court following recent pleas by the civil society and parliamentary standing committee recommendations are increasingly deterring approvals for clinical trials, as well as new drugs.
DRUG TRIALS & TRIBULATIONS

• Drug regulators in emerging markets have changed various norms and guidelines for allowing the sale of generic medicines, causing delays in approval processes, as well as launch of medicines
• Brazil’s ANVISA’s new approval process has increased the product approval time there to 48 months from 36 months, affecting Glenmark, Torrent and Cadila Health
• In Russia, a major market for Indian firms, the new regulatory directive mandates clinical trials for generic products, too
• The Drugs Controller General of India has constituted several new advisory committees to oversee clinical trials, new drug approval processes, etc