The CDSCO Chennai office will shortly submit a comprehensive report to the DCGI about the illegal business practices involving expired drugs that has been going on in south India mainly in Tamil Nadu.
According to sources, the DCGI office in Delhi is closely monitoring all developments relating to expired drugs in the country especially after unearthing of the huge racket in expired drugs in Chennai.
Sources in the office of the south Zone ACDSCO said the cases related to the illegal trade practices are state issues and therefore state drug authorities have give more attention to this issue. “However we will help if we are asked,” Shanthy Gunasekaran, the ADC in charge of the CDSCO said.
When asked what initiative CDSCO south zone has taken during the recent action by the state drug control department, the ADC replied that the office is checking the developments one by one and also watching how the manufacturers are recalling the date expired drugs from the market.
“We are assessing the situation more than the routine work. We will send the report to the central office soon. But currently my office is concentrating only on those companies which have GMP facilities,” Shanthy Gunasekaran said. According to her in Tami Nadu there are more than hundred companies having GMP facilities. She clearly pointed out that the CDSCO has no direct control on these companies.
To a question whether the state authorities have sought CDSCO’s assistance during the crisis, the ADC replied negative. To another question, if the CDSCO has offered any help to the authorities in the state, her reply was “We were not asked, so we didn’t”.
While interacting with Pharmabiz, M Bhaskaran, the director of State Drugs Control Department said, “If I were in her position in the CDSCO, I would immediately approach the state authorities and offer all the assistance. So far she didn’t approach me.” He added that all the problems were sorted out with his staff only and no help received from the central agency although there were some inter-state links to the business in expired drugs.
”Based on CDSCO’s interference, many questions are coming from different corners. They have not approached me so far, I have also not contacted them,” an aggrieved Bhaskaran told Pharmabiz.
According to the ADC of the CDSCO, this is a state issue which is mainly controlled by the state authorities. The issue is regarding the sales which the state authorities have to look into. “We are short of inspectors and other staff. However, we are closely monitoring the issue,” she responded.
“We are sorting out the issues and taking assessment of the manufacturing units how they are recalling the expired drugs and destroying it. After the assessment we will submit the report to the DCGI. Along with this, I have to concentrate on the CoPP issue also,” she said.