Sunday 1 December 2013

035. Major pharma companies behind vigilance raid: Drug Control Officers.

Major pharma companies behind vigilance raid in drug control offices in Kerala: KSDCOA

By Pharma Biz. Com

Peethaambaran Kunnathoor, Chennai
Friday, August 17, 2012

The Kerala State Drugs Control Officers Association (KSDCOA) has said that the allegations being levelled against the state drug control administration by a section of the media on account of a state-wide vigilance raid at the drug control offices last week are baseless and ill-motivated.

According to the Association, there are certain major pharmaceutical companies behind the vigilance raid, against whom the department has recently initiated punitive action for violations of various sections in the Drugs and Cosmetics Act (D&C Act).

KSDCOA has admitted that a performance audit conducted at the DC offices by the office of the Accountant General last year had raised the eyebrows of the auditing officers on the functioning of the enforcement officers. The association said the reason for the AG’s criticisms were due to lack of awareness about legislation and ground realities.

The enforcement officers said Rule 63 of the drugs and cosmetics rules stipulates that once an application for renewal is received on time, the licence is deemed to be in force until the application is disposed off. So there is no need of worry in any way for the trader or dealer. However, they maintained that the reason for the delay in issuing the licence was shortage of staff in the offices.

Regarding delay in issuing test results of samples, the association said the D&C Act foresees no role for the drug control officers in testing of drugs, which is the duty and responsibility of the government analysts attached to the drug testing laboratory. But the officers have admitted that most of the test results are obtained after the drugs were consumed by the patients. Here also, the officers found the reason for the delay is shortage of staff, machinery and laboratories.

By reiterating the fact that the state authorities have no role in price fixation of drugs, the drug control officers said they have not shied away from taking punitive actions against the dealer whenever a case of charging of excess price or refusal of drugs was detected.

While admitting that there are instances of corruption in the department as in other spheres of life, they said several of the officers are doing honest job to keep the state free from spurious and sub-standard drugs. They claimed that Kerala drugs control department is the first government agency in the country to launch prosecution against the pharma companies which had refused supply of drugs to a section of traders at the instance of All Kerala Chemists & Druggists Association (AKCDA). The incessant flow of drugs to the state owned Karunya Community Pharmacies has taken place due to the intervention of the department by initiating action against AKCDA, the association opined.


Republished here by courtesy of Pharma Biz.Com





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