The Prime Minister’s initiative to improve India’s ranking in ‘ease of doing business’ index to 50th position from the current 134th is unlikely to get a favorable nod from the pharmaceutical industry of Pondicherry as the cumbersome procedures in licensing and renewal of applications due to bureaucratic interference become a bottleneck for industrial growth in the Union Territory.
In the last six months, more than 10 SSI units have been closed down due to the complex and tardy regulatory procedures introduced by the health department.
According to sources, the health secretary has given instructions to the regulatory officials that decision on all the applications and representations reaching the offices of the DC department should be made only after an endorsement from his office. The health secretary has issued the directive because of alleged incidents of manufacture of unapproved drugs by certain companies a few years ago, followed by it an inspection by central investigating agencies.
Although the plan of the central government is to make it easier to do business in any part of the country, it is becoming harder for the pharma industry in Pondicherry to survive the situation. In the last six months, more than 10 SSI units have been closed down due to the complex and tardy regulatory procedures introduced by the health department.
“Now-a-days, no unit, whether from allopathy or ISM sector, is getting either a product licence or a renewal. The applications submitted by the industrial units keep on lying on the table of the health secretary for months, and without his consent no enforcement official could do anything”, sources said.
Industry sources told Pharmabiz that the state government is not giving any incentive to the local industry either by price-preference or by any revival package for the sick units. Instead of improving the industry, the government is killing it. The industrial sickness is alarmingly increasing in the pharma sector.
According to them, the bottleneck for pharma industrial growth in Pondicherry is not the Drugs and Cosmetics Act, but the bureaucratic management. Till three years ago, the drugs control department was controlling the manufacturing and trade sectors and their regulations had in no way affected the industrial growth. Now, the UT’s health secretary, who handles more than seven departments, is interfering in each and every operation of the enforcement authorities, which creates inordinate delay in clearing applications.
They further said no positive step is taken from the health minister level or from the chief minister’s office either to remove all the barriers or to simplify the procedures in spite of repeated requests made to them by the industry. Since Pondicherry is one of the union territories, the industrial association under the leadership of IDMA is looking for help from the union government.
Including Indian systems, Pondicherry has 130 manufacturing units with GMP facilities. Out of this, four units are WHO GMP certified. Ten more companies are waiting for the WHO GMP certification. Several companies are engaged in contract manufacturing services with MNCs. If the bureaucratic interference continues to exist, all the pharma industrial units will be vanished from Pondicherry, sources said.