Rougher Passage to India’s Drug Market | Healthcare in India |

FDA Commissioner Margaret A. Hamburg, M.D., contrasted the craftsmanship and beauty of India’s Taj Mahal with recent lapses in quality by “a handful” of the country’s drug manufacturers during a recent visit there. If the comparison was meant to flatter the domestic pharma executives and regulators with whom she met, they didn’t appear to think so.

Dr. Hamburg and officials from India’s Ministry of Health and Family Welfare pledged cooperation in data sharing and even “medical and cosmetic product and inspections conducted by the other Participant.” That’s no small promise since India is the world’s second largest exporter of prescription and over-the-counter drugs. Yet their formal Statement of Intent conditioned such cooperation “as time and resources allow” and didn’t set specific terms.

In a conference call with reporters today, Dr. Hamburg said implementing the statement was a five-year commitment “already under way” as both countries “have already embarked upon some cross-training activities and started to identify some critical areas for future activities together, so I think progress will be made.”

Indian drugmaker Ranbaxy has come under repeated FDA scrutiny. It agreed last year to pay a $500 million fine for safety and record-keeping violations. More recently, it urged Dr. Hamburg to lift the FDA’s consent decree. Extended as of January, this decree effectively bans four of Ranbaxy’s Indian plants from exporting active pharmaceutical ingredients to the United States. Although Ranbaxy contended that it needed the export activity to fund FDA-sought quality improvements, Dr. Hamburg declined the company’s request.

Domestic Generics

According to the All India Chemists and Druggists Association data reported by Indian newspaper The Economic Times, Mumbai-based Glenmark Pharmaceuticals impacted the Rs 3,000 crore ($483.7 million) Indian diabetes drug market long dominated by multinationals last year. Glenmark racked up Rs 16 crore ($2.58 million) in eight months for its Zitamed and Zita generic versions of sitagliptin

These generics sold 30% cheaper than the Januvia and Janumet branded drugs of market leader Merck & Co., which generated more than $5.8 billion in combined global 2013 sales for Merck and are the subject of a patent dispute between the companies.

Through court decisions and regulatory actions, Indian officials have pressed foreign-based multinationals for lower-cost drugs. These multinationals, however, have argued that Indian actions hinder their ability to do business selling innovative if costlier drugs.

Patent Questions

India’s Patent Office sent shivers through the biopharma industry in 2012 when it revoked the exclusive patent rights held by Bayer for cancer drug Nexavar, and awarded the nation’s first-ever compulsory license to a domestic maker of a much cheaper generic. Industry cringed again last year when India’s Supreme Court rejected patent protection for Novartis’ blockbuster cancer drug Glivec, as the drug faces a 2015 expiration of its first U.S. patent.

The patent decisions, Bagla explained, reflect Indian compliance with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization, of which India is a founding member.

“Western companies need to factor this situation among the risks of doing business in India,” Bagla emphasized. “Some of our clients are limiting their involvement in India due to this. Others are a taking a measured approach to what products and technologies they bring. Very few are walking away from India completely.”

Legal and Regulatory Moves

Last year, the Indian Supreme Court ordered a nationwide halt to clinical trials for 157 new chemical entities, citing the need for stricter ethical standards after seven girls died in a Phase IV trial of an HPV vaccine carried out on children unaware they were under study. The court also shifted responsibility for trials from the Central Drugs Standard Control Organization headed by Dr. Singh, ordering India’s Health Secretary personally responsible for new-drug clinical trials.

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