Counterfeit drugs creating a challenge for the regulators in India

According to Government-sponsored studies around 3% of medicines in the Indian market are of poor quality or are counterfeit. However, a report published by ASSOCHAM said that 25 percent of medicines sold in India re either counterfeit or of poor quality. Generic drugs like Crocin and Betadine have earned a bad name due to the menace of counterfeiting.

According to former International Pharmaceutical Federation vice president Prafull D. Shah, “Any study showing a higher percentage of Indian drugs as substandard or fake serves the interest of foreign pharma companies since Indian companies have always posed them a threat.” He also said that he had asked ASSOCHAM for the data based on which they provided the 25% figure however they never provided it to me.

The BJP government in 2003 had appointed an expert committee to assess the regulatory infrastructure and the scope of the problem of fake and cheap drugs in India. The panel admitted that there was an absence of scientific and detailed investigation to reveal the exact estimate.

The committee also said, “The Central government should provide assistance to undertake such scientific and statistically-significant study for a clear picture about the exact extent of spurious drugs in the country.”

In 2006-07 with the support of WHO around 7500 samples were collected and tested from across the country out of which 3.12% were of poor quality but the presence of spurious drugs was negligible.

In the second survey, conducted by the Central Drug Standards Control Organisation (CDSCO), a total of 24,780 samples were tested from around 40,000 pharmacies, of which 644 were “SALA (sound-alike and look-alike)”.

Going by raids conducted in the past few years, prominent places where counterfeit drugs are manufactured and sold in wholesale include Baddi in Himachal Pradesh, Agra, Aligarh, Bulandshahr and Muradnagar in Uttar Pradesh, Patna in Bihar and several places in West Bengal.

Source: OutlookIndia.com