By Arun Pratap Singh
Dehradun, 23 Jul: Samples of many drugs manufactured by pharma companies in Uttarakhand have failed the quality test yet again. If such a trend continues, then serious questions are bound to be raised regarding the quality of drugs manufactured in the state and this is bound to adversely impact the pharma industry here. The Pharma Industry is treated as a sunrise industry in Uttarakhand. The administration has to strictly monitor the quality of the drugs being produced in order to keep the reputation of pharma industry in Uttarakhand intact. Ironically, samples have failed of some leading drug companies having units here, also, which points to the need for greater monitoring of the quality of the drugs manufactured in the state.
The Central Drugs Standard Control Organisation has been collecting samples and testing the quality and standards of medicines being made by pharma companies across the country. As part of this, in the month of June, the Central Drugs Standard Control Organisation had collected samples of several drugs manufactured in the state by various pharma companies. After investigation, the Central Drugs Standard Control Organisation has released its report. Samples of five medicines manufactured in Uttarakhand have failed in the investigation. According to the released report, the quality of 31 medicines manufactured in various states of the country has not met the standards. Due to which the Drugs Standard Control Organisation has issued an alert. Along with this, instructions have been given to the Drug Controller of the states to take action against the guilty manufacturers.
In view of this, Uttarakhand’s Drug Controller Tajbar Singh has issued orders for recall of the entire batch of drugs in question which were found to be substandard from the market. These drugs have been made by many pharma companies located in Uttarakhand. The pharma companies whose drug samples have failed are located in Roorkee, Haridwar and Kashipur.
In the past four months, every month, some drug samples being collected have not met the quality standards. In fact, in the month of March, samples of 10 drugs were found to be substandard. Similarly, in the month of April, samples of 12 drugs manufactured by 10 pharma companies failed. In the month of May, samples of 8 drug samples manufactured in Uttarakhand failed the quality test. At the same time, in the month of June, samples of 5 medicines manufactured in Uttarakhand have failed. Thus, so far, samples of 35 drugs manufactured by various pharma companies in Uttarakhand have failed quality tests.
Samples of the drugs that have been manufactured in Uttarakhand and have failed quality test in June included those of Glensmith Labs Private Limited’s Esomeprazole Gastro-Resistant Tablets 40 mg, manufactured on behalf of Glensmith by Skymap Pharmaceuticals Private Limited located in Roorkee; sample of Ranitidine Hydrochloride Tablets 150 mg manufactured by Francis Remedies (India) Private Limited also in Roorkee; sample of Tranexamic Acid Tablets 500 mg manufactured by Omega Pharma from Haridwar; sample of Pantoprazole Gastro-Resistant Tablets 40 mg manufactured by Agron Remedies Private Limited from Kashipur and the sample of Etoricoxib Tablets 90 mg manufactured by Apple Formulations Private Limited also based in Roorkee.
Experts opine that unless the provisions of law become stricter and provide for harsh punishment, to ensure manufacture of quality drugs will remain big challenge for the authorities. India is among the top pharma exporters in the world and unless the laws to ensure quality are made stricter, Indian pharma sector will face challenge to keep its reputation intact globally.
