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Seventy pharma units shut down in Telangana with tightened pollution and licensing norms

A Raju, Hyderabad
Monday, May 15, 2017, 08:00 Hrs  [IST]

Pharmaceutical industry in Telangana is in a serious dilemma with the state Pollution Control Board imposing numerous restrictions on drug manufacturing activity on the one hand and on the other drug control administration is making its licensing conditions more stringent for new drug approvals.

During the past one month as many as 70 pharma companies were forced to shut their shops in Hyderabad as they are not able to comply with increasing restrictions and growing costs.

According to industry experts, the bulk drug units and other red category industries located in and around Hyderabad are going through tough time. With stringent regulations from the PCB many units have either shut their operations or struggling to stay afloat in the business.

On one hand the government is claiming to support the industry and help it build international standard infrastructure facilities but on the other the environmental protection and drug licensing agencies are implementing stringent regulations which are acting as hurdles for the industry’s expansion.

It is in the wake of these developments, the 70 units had to stop their operations. “We have been facing unreasonable restrictions from the pollution control board more particularly on product changeovers. This has created lot of pressure on the pharma industry in Hyderabad and the situation is pathetic,” said N V Narender, general secretary of Telangana Association for Pharma and Chemical industries (TAPCI).

At present there are 340 bulk drug and other related chemical industries located in Hyderabad and surrounding areas in Telangana and most of these manufacturing units are categorized into red industries and set to be relocated outside of the ORR by the government. However the action plan is still in the making as the government is yet to develop the pharma clusters to fully accommodate these polluting units.

Hyderabad is known as bulk drug capital of the country, but it’s fast losing its business activity on the domestic front and export edge in the global market observed the TAPCI general secretary who is also a member of task force for the newly developed Pharma city in Hyderabad.

It is sad that the PCB is strictly implementing factory license rules and other state regularization processes which all have become stumbling blocks for the industry’s growth in the recent past. It is alleged by the industry that recent norms implemented by the PCB are not allowing the industry to innovate. Hence, product changeovers are not possible in the state. In addition to this, higher production costs and government restrictions are taking a toll on the industry, say industry experts.

Units making active pharmaceutical ingredients (API) are already facing increasing competition from Chinese firms. “While on one hand the central government is announcing support to the industry but on the ground the reality is totally different. We urge the central government to extend subsidy support and speed up the approval process for new drugs,” said Jayant Tagore, executive director of Bulk Drug Manufacturing Association (BDMA).  

During the last decade, Indian API manufacturers lost their competitive edge to countries like China, primarily due to costly power, inadequate infrastructure, government restrictions on the volume of APIs produced in the existing plants, lack of financial support and incentives from the government, to match the Chinese.

According to Narender, the policy restrictions by the government are creating hurdles for product innovation. In addition to this, getting license for manufacturing new product from the PCB and the drug controller departments has become very tough. “Without allowing the industry to innovate industry cannot grow. As the industry is already complying with all the environmental norms prescribed, the Telangana government should liberalize its licensing procedures for new products so that it will help the industry to expand and grow with innovative products as per the market demand,” observed Narender.

 

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