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The inordinate delay in appointing a State Licensing Authority (SLA) at the drug control department for issuing various licenses and statutory certificates required for pharma and cosmetic manufacturing industries, pharma exports and medical devices industry is dealing a crushing blow to the pharma sector in Tamil Nadu, thanks to the apathy of the health and family welfare department.
It is learnt from industry sources that the office of the drugs control department at the DMS Complex is now in a standstill mood as no official business is taking place with respect to industry needs, mainly on applications submitted by drug manufacturers, pharma exporters and cosmetic industry.
The manufacturers of low-risk medical devices, Class A and Class B, are also supposed to apply for licences to the SLA office, but they are also facing hurdles in their operations in the absence of a licensing authority in the state.
In Tamil Nadu, most of the pharma industries are under MSME sector, but they contribute nearly 10 per cent of the total pharma exports from the country to foreign markets. For the last three weeks, the entire operations of the export groups are hampered because of not issuing required licences and certificates by the drug control authorities. Since no licence is issued, many of the companies dealing in exports are becoming the worst lot because they are unable to ship their products abroad. As per Drugs and Cosmetics Act, the approvals should be granted by the SLA. Approval pending creates a big loss of revenues to the companies as well as to the state exchequer.
While talking to Pharmabiz, the industry sources said more than 600 applications are pending with the department for the last 24 days. They wanted the government to appoint one SLA immediately to solve the crisis. Delay in issuing licences and statutory certificates required for exports are putting the exporters into quandary. The same situation is prevailing in the case of the manufacturing industry also. They are applying online and offline applications for approvals, but nobody is there in the office to approve them. Every day one or two files of each company are reaching the drug control office for approvals.
An exporter while talking to Pharmabiz in anonymity said, every exporter has to comply with the conditions of export orders given by the overseas buyers. If they are not falling in with the order as per the terms and conditions, the buyers will cancel the orders and find out new exporters from other states. This will create a huge loss to the state pharma exporters. He said it is the duty of the department to support the industry for smooth operations and added that there was no problem in the industry until last month.
The drug manufacturers and the exporters need several licences such as CoPP, export licences, free sale certificates, new drug endorsement, renewals, etc. Further, the research and development laboratories, clinical trial laboratories, drug testing laboratories, neutraceutical companies and cosmetic industries are also in need of approvals from the SLA office. All the operations of the industry and exports are depending on the drug control office and the SLA. Now all the operations of the industry seem to be paralyzed because of absence of approving authority.
After the retirement of J Vijayalakshmi, the in-charge director of the department, on April 30, the government gave the charge to the joint director M Sridharan on May 10. However, after three days, the government placed one senior civil service officer, the commissioner of the department of food safety, on the top of the department as director but not appointed a licensing authority. As per provisions of the drugs and cosmetics act, an officer with pharmacy background and five years experience in enforcement activities is only eligible for holding the post of licensing authority.
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