Who is he?

Dr. Gyanendra Nath Singh is currently the Drug Controller General of India at the Central Drugs Standard Control Organization (CDSCO), a post similar to the U.S. Food and Drug Administration (FDA) Commissioner.

Why is he in the news?

The U.S. FDA Commissioner Dr. Margaret Hamburg visited India in February 2014 to strengthen cooperation between the two regulatory counterparts. Dr. Hamburg’s visit was crucial, for while India is the second largest provider of finished drugs to the United States, four Indian companies have faced FDA sanctions on quality control in the last two years.

When approached about these issues of quality control, Dr. Singh, in an interview stated, “If I have to follow U.S. standards in inspecting facilities, we will have to shut almost all of those.” A subsequent clarification was issued by the Ministry of Health stating that any Indian pharmaceutical product entering the U.S. market complied with U.S. standards.

Dr. Singh did articulate the need for joint audits and inspections to help Indian drug regulators meet international standards, but went on to affirm, “the FDA may regulate its country, but it can’t regulate India.” Recent events such as these have overshadowed many drug manufacturing facilities in India that follow good manufacturing practices.

What can we expect from him?

To address the issues of drug quality control, the FDA and India’s drug regulators signed a 10-point agreement to achieve, among other things, a convergence in regulations.

Dr. Singh has been slow to point out the tangible steps he will introduce to the Indian drug industry, making it difficult to assess potential outcomes of the agreement. Instead, his attempts to assuage public concerns of the industry have garnered more attention, and resulted in bad press internationally.