The law and Indian medicines in the USA

Professor Amir AttaranCanada Research Chair

Institute of Population Health and Faculty of Law

How India’s drug laws work• India’s “FDA” is the Central Drugs Standard Control Organization (CDSCO).

India’s “FDA Commissioner” is the Drug Controller General of India (DCGI).

• The constitution gives both Federal and State governments regulatory powers. These are divided rather schismatically.

• The Federal drug safety laws are obsolete: both the Drugs and Cosmetics Act (1940), and the Rules (1945) remain in force. Later amendments (e.g. 2005) have not kept pace with global standards.

• There are extremely dangerous lacunae in India’s obsolete laws.

Lacuna 1: CDSCO oversight is short or lacking• CDSCO regulates “new drugs”, in the sense of novel therapeutics. The legal

definition of “new drugs” excludes new generic medicines (Rules, s. 122E)

• Yet CDSCO has jurisdiction over “new drugs” for just four years, and even that is practically lacking. The States, not CDSCO, have constitutional jurisdiction to license facilities, monitor products and prosecute violations.

• Medicines which are not “new drugs”, such as new generic versions of old drugs, are never within CDSCO jurisdiction. Only the States can.

– The schismatic properties of India’s constitution means that generic medicines which India is famous for are not federally regulated.

Lacuna 2: CDSCO and drug substances for export• Despite the foregoing, CDSCO has jurisdiction to certify that exports meet meet

WHO standards for “Good Manufacturing Practices”.

• CDSCO’s standard operating procedures (SOP) are designed to pose minimal bother for drug exporters. The SOPs specify:

– There are no surprise inspections– Industry self-assessment is the norm

• This is the inspection scheme with which FDA has said it will partner.

[ … ]

CDSCO’s attitude on the US-India Statement of Intent• After FDA Commissioner Hamburg signed the Statement of Intent, the Drug

Controller General of India, Dr GN Singh, said:

“We don’t recognize and are not bound by what the U.S. is doing and is inspecting. The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”

• The Statement of Intent does nothing to give FDA legally-binding inspection powers in India. On the contrary, the Statement of Intent reads that it “does not create [any] rights or obligations”.

Points for discussion and thought• Is it wise of FDA to do joint inspections with a recalcitrant partner like CDSCO,

when that “lifts the veil” and reveals secrets of FDA inspectors’ tradecraft?

• Is it wise of Congress to appropriate tax money for 19 FDA inspectors based in India, when India itself refuses to fund CDSCO inspectors sufficiently?

• By subsidizing India this way, is Congress making Americans over-dependent on Indian drugs of uncertain quality, while killing drug manufacturing jobs here?

• The FDA should regulate medicines more like the FAA does aviation. FAA’s cares less about inspecting foreign airlines, than demanding equality from foreign governments’ aviation regulators. Foreign airlines only into American airspace if their home country regulator meets global standards, the same as the FAA. Lesson: the quality of the regulator matters more than the quality of the airline (or medicine) should.

Thanks for your patience:

aattaran@uottawa.ca