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The top level officers in the health department and the senior officers at the drugs control administration (DCA) under the Government of Telangana should create conducive operational atmosphere for the pharma manufacturing industry, especially for the small-scale and medium level formulation units, to operate freely in compliance with all the norms of the Act and the Rules.
Stringent norms and rigid enforcement activities will discourage the entrepreneurs from jumping forward and often put them into trouble. The formulation industry of Telangana enjoys a reputation for quality products and services and there is no distinction between products of larger units and of small-scale industries working in Telangana, says Dr PV Appaji, former director general of the Pharmaceuticals Export Promotion Council of India (Pharmexcil).
“As far as the medicinal products manufactured by the big players and the MSMEs in Telangana are concerned, the quality of the products of both the sectors is the same and no complaint is coming from any part of the world. All the MSME units and the corporate sector manufacturers follow the same principles. Hence Telangana’s pharma industry has very less defects in their production process and in quality aspects when compared with those of other states. The number of NSQs declared by the regulatory bodies is also less in Telangana,” he told Pharmabiz in a telephonic interview.
Concerned over the pathetic status of the MSMEs, Dr Appaji opined that the industry association itself can build a conducive atmosphere for growth provided they hold regular interaction with the Department of Pharmaceuticals (DoP) under the central government as well as go side by side with the state government. The DoP has several plans to boost up the industry and it funds under various schemes to the MSME units. The association should utilize such schemes for the benefit of their member units. In the same way, the government of Telangana is providing all support to the pharma sector. Fortunately, the ministers of the industry and the health departments are experienced persons with good vision for the future. The present secretaries of the departments are also experts in their areas. So, this is the best time for the pharma sector in Telengana to prosper, he said in response to a question from Pharmabiz.
Sharing further information, Dr Appaji, who is now advisor to several industry associations including Indian bulk drugs manufacturing industry, said the MSME sector has to become proactive in their vision and in the dealings with government officials. The association should apprise the government and the officers of the necessity of an industry-friendly approach by the regulatory officials. Currently, the regulatory officers are reportedly behaving in an arrogant and hostile manner. The association should inform the chief minister, the health minister and the industry minister about the way the enforcement agency is acting and want ministerial level intervention in the matter to solve the issues. At the same time, the association should make all attempts for regular interaction with the top bureaucrats and the ministers under central and state governments.
Further, Dr Appaji suggested that there are senior industry experts, policy experts and pharma ideologues in Hyderabad. The drug manufacturers should seek their advice and suggestions for the industry’s development. He said everybody in Telangana and in Andhra Pradesh knows that the pharma MSME units are in trouble and in struggles due to the rigid enforcement activities of the drug control department.
An industry person in Hyderabad, in anonymity, told Pharmabiz that the department of drug control in Telangana and also in Andhra Pradesh is headed by senior civil service officers who always stick to rules and regulations specified in the book. They do not want to know the problems of the industry or the exertions taken by the entrepreneurs. He said because of this strict method of enforcement of drug rules, no new entrepreneur is coming forward to start a pharma unit.
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