No checks in place, all pills can't cure ills

Hyderabad: One in ten medical products in the Indian market is of poor quality, substandard, falsified or spurious and yet the industry is growing at 25 per cent every year according to a recent assessment by pharmaceutical industries. 

Complaints to call centres of pharma companies and to drug controllers pour in from pharmacists about the quality of batches they are supplied and complaints from patients that the drugs are not effective.

Random sampling of medicines is not carried out as much as it should be because there are not enough inspectors to carry out this process and for that reason self-reporting is being very heavily relied on.

Dr Sai Kumar Katam, national president of Doctor of Pharmacy Association of India says, “Patients don’t know why the medicine is not working and often they complain to doctors or pharmacists who then register complains in call centres. When regular patients suffering from diabetes, hypertension or other co-morbid conditions complain of medicines not working effectively is a direct indication that there is some problem in the chemical combination.”

There is no regulatory authority that tabulates the complaints to authenticate them. The government relies on pharmacists and drug inspectors to control the circulation of counterfeit medicines. In the Mashelkar Committee Report submitted to the government, pharmacists have been asked to stock medicines from regulated companies and not succumb to the financial inducements of small unscrupulous manufacturers. The report says the government must appoint drug inspectors who will regularly pick up samples and check them out.

Joint director of TS drug control department T. Kailasam says “We now have drug inspectors who are carrying out random sampling. There are ten vacancies to be filled but there are inspectors moving in the market. The retail outlets are spread far and wide and it is important for them to stock products of authorised companies only.”

The Central Drugs Standard Control Organisation has proposed carrying out joint inspections with state authorities to curb this menace. They have also identified medicines that are in very high use, and are now developing a system to track and trace these products with labels.  

According to sources, CDSCO has identified 300 brands that are in high demand and is working out a system to track them to check if there is any tampering during transit or at the end point.