India Says Other Regulators Will Have Access to Export Database

Posted 25 June 2015 | By Michael Mezher 

India Says Other Regulators Will Have Access to Export Database

India is planning to make a database used to track drug exports available to regulators and companies around the world, The Economic Times reports.


In recent years, India has faced allegations that manufacturers within its borders are producing and distributing spurious and counterfeit drugs.

In response to these allegations, in 2009 the Central Drugs Standard Control Organisation (CDSCO) launched a survey to determine the extent of the country's spurious drug problem. The survey found only 11 of some 24,000 samples tested were found to be falsified, a rate of only 0.046%. Out of 305 samples that underwent chemical analysis, the regulator said "only 3 were found to be substandard with respect to the … active ingredient mentioned on the label." However, the survey's methods and results have been called into question, most prominently by Roger Bate of the American Enterprise Institute, who called the report "little more than a whitewash of this crucial problem."

Indian companies have also been hit with numerous warnings and sanctions from global regulators over manufacturing and data integrity issues. These issues have led to concerns about the quality of drugs and pharmaceutical ingredients exported from India—exports that are expected to be worth more than $16 billion (USD) this year.

Track, Trace, Transparency

In an effort to build its reputation for quality medicines and distance legitimate products from counterfeits, India recently announced it would require exporters to include manufacturing data on all levels of packaging used to transport drugs out of the country.

According to the government, this data will be used in a "track and trace" database that will allow regulators to tell where drugs are manufactured and make it easier to identify counterfeits.

Now, The Economic Times reports, the Indian government is planning to open up the database to other regulators and companies in hopes of alleviating concerns about falsified drugs from the country. A senior commerce ministry official told The Economic Times that a selection of companies will participate in a pilot of the database at the end of June 2015.

Indian companies have resisted the increased labeling requirements on drug packaging and successfully campaigned to delay the requirement to place barcodes on primary product packaging that was to go into effect in July. Speaking to The Economic Times, S. V. Veeramani, president of the Indian Drug Manufacturers' Association, said companies are looking to the government for guidance on uploading information to the database, and while they are "willing to participate" in the process, they are "not sure of its benefits."


The Economic Times

Categories: Regulatory News

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