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.

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.

Hours after the US drug regulator banned imports from a fourth factory of Ranbaxy Laboratories Ltd, the drug controller general of India G.N. Singh chose to back the Indian company, saying the current situation may not require withdrawal of its medicines from the local market.

On Friday, the US Food and Drug Administration (FDA) barred Ranbaxy, a subsidiary of Japan's Daiichi Sankyo, from producing or distributing drug ingredients manufactured at its Toansa facility in Punjab for the US market.

The FDA has already banned imports from Ranbaxy's plants in Mohali in Punjab, Dewas in Madhya Pradesh and Paonta Sahib in Himachal Pradesh. At the Toansa facility, the regulator found the company's staff found that workers retested drug products to produce acceptable findings after the items originally failed analytical testing. While the US has banned imports from these facilities, the Indian pharma market continues to use raw materials from these plants. Singh in an interview said, "Indian pharmaceutical companies cannot be judged by American standards." Edited excerpts:

Were the other three plants of the company found to be in violation of India's Drugs and Cosmetics Act?

We had approached them last year after US FDA flagged certain issues. Some of those were found to be true and my office had told Ranbaxy to take corrective measures. Similar procedures will be followed in this case as well. But I do not think this is a situation which will warrant withdrawal of drugs from the domestic market. Our biggest objective is to maintain good quality of medicines and we are doing that. There are no drugs in the Indian market that are not up to the standards stated under the Drugs and Cosmetics Act. We will shortly be in touch with Ranbaxy's management to find out what went wrong at the Toansa plant.

Will such decisions adversely affect India's image as a manufacturer of safe, affordable drugs?

As of today, India supplies low-cost drugs to over 200 countries. Our pharmaceutical sector is a huge success. We cannot be doing well if our drugs were of substandard quality. Many multinational pharmaceutical companies stand to gain if India loses its image as a supplier of quality drugs. However, we will take appropriate action. We are in the process of streamlining the drug regulation in India and fundamental changes will be taking place soon. I am not worried about issues of quality

Read more: http://medcitynews.com/2014/01/indian-pharma-firms-cant-judged-u-s-standards/#ixzz2rNuMeTBQ