Chennai: In a high level official reshuffle in the drugs control administration in Tamil Nadu, the state government has bifurcated the powers of the SLA between two licensing authorities by assigning the joint director PU Karthikeyan with powers for licensing blood banks, blood storage centres, medical devices industry and cosmetic manufacturing units, and the ADC Habeeb Mohammad with the power to license manufacturing of allopathic and homeopathic drugs.
For the last eight months, Mohammad has been continuing as the SLA for manufacturing of allopathic and homoeopathic medicines as well as for the medical devices and cosmetic industries. Because of the workload of his office team, the applicants had to wait a long period to avail the services of the SLA office. The major issue was the inordinate delay in getting a licence or renewal or any certificate including CoPP from the office of the SLA. As a result of this, the industry associations, both the TN IDMA and the TN PMA, personally met the health secretary and briefed him about their problems. Accordingly, the government has now divided the powers of the SLA between two officers, sources informed.
In addition to this, there was an allegation from the industry that the attitude of the SLA towards the industry was not supportive and helpful and his way of behavior would tarnish the image of the government which is extending maximum support to the pharma sector. But the officer in the rank of the licensing authority was allegedly putting the industry into severe trouble, said a medical doctor who runs a medical devices industry. Mohammad is very reluctant to reply to queries even from the media also. Sources from the department said he is an officer of the rank of ADC, but the government appointed him as SLA last year. He retires on May 30 this year.
Last month the government promoted PU Karthikeyan from the post of deputy drug controller (DDC) to the position of joint drug controller (JDC) and now he has been given the assignment as licensing authority (SLA) for medical devices, blood banks and cosmetic manufacturing. He is now the second joint drugs controller (JDC 2) in the department.
Talking to Pharmabiz, Karthikeyan said a three member committee of drug inspectors will be formed under him as per the government order to supervise the licensing system. He and his team will work as a dedicated group of officers to support the industry and their problems will be sorted out very shortly. No deliberate delay will be made to issue any licence to any applicant, but application analysis and licensing procedures will be carried out as per the laws and on government directions.
He said there are 96 blood banks under the government sector and 240 units under the private sector in Tamil Nadu. Besides, there are 10 blood banks operated by central government institutions like ESI and Military hospitals. The number of stem cells banks is 3.
Across the state there are 400 government controlled blood storage centres and in the private sector 165 centres are operating. Licences to these blood centres are issued jointly by the Central and state authorities.
As regards medical devices industries, he said 150 licence holders are there in the state, but the number of cosmetic manufacturers is 270. He said several applications have been received by the office for licences to blood banks, medical devices and cosmetics and they are all pending for the last several days, but all of them will be sorted out soon. He took charge on Monday.
Welcoming the decision of the government for bifurcation of assignments of the SLA between two officers, the controlling authority of the department (TN DCA) MN Sreedhar said with this new reform of the health department, the workload of the SLA office can be reduced and the people will get the services without delay.
However, it is learnt that the pharma industry captains in the state are not satisfied with the exercise now initiated by the government. An industry leader told Pharmabiz that they encounter a severe technical problem which needs to be sorted out by the government in order to support the industry. According to him, the department lacks a technical head, so that they cannot report their issues with a higher authority. The director of the FDA and the health secretary are representing the bureaucracy, hence the poor industry persons from the small and medium enterprises are unable to approach them and apprise of their sufferings. The industry wants a technical person from the department as the director of the DCA.
