The drugs controller general of India (DCGI) and his team made an attempt to address the impending problems and concerns faced by the all India pharma indenting agents association (AIPIAA) in a one day workshop organised by CDSCO and AIPIAA to discuss various issues faced by the industry. The aim of the workshop was to educate the intending agents about regulatory laws in the country by the CDSCO which in turn helps better regulations and fast registrations of the pharmaceutical ingredients.
The DCGI said that its the first time the DCGI's office is having a meeting with an association but stressed that such kind of meeting is important to create awareness and urged to have more of such meetings and workshops so that they can work and co-operate together with the importers. “Such discussions will help in creating better understanding between the importers and the regulators and will help in increasing trust and confidence in each other,” Dr Surinder Singh, DCGI averred.
Dr Singh took this opportunity to inform many strategic decisions that the DCGI's office is pondering to make in the coming months with a view to strengthen the country's image in the international market. He informed that Indian pharma sector industry size is growing at the rate of 14 percent per annum and that its a one lakh crore (US$ 20 billion) market. He pointed out that the Indian pharma industry is recession proof where the exports have grown at about 10 percent per annum during the most testing period. According to the statistics presented by Dr Singh the latest figures show that India's export market is worth Rs 42000 crore (US$ 9 billion).
“Quality plays a key role in this and all the stakeholders have to ensure that it is maintained in the future as well. There is too much competition in the market and only delivering product that are high in quality will help us to retain this position and it is the responsibility of both the regulators and all the stakeholders to ensure this.”
Indian pharma companies filed more than double DMF's in 2009 in the US compared to the US companies which is a great achievement. The DCGI said that his aim is to make India, pharmacy of the world in a decade and become a global gateway for drugs and discovery. Giving a word of caution he warned the industry to gear up faster since there isn't too much time left for the implementation of the new pharmacopoeia that's going to be implemented from September 1 this year. He also informed about starting a data bank from August 1 for keeping a tab on the clinical trials in the country.
B R Sikri, president of the AIPIAA explained many issues that the agents faced and requested the DCGI to ponder over it. One of the important issues that he brought to the regulators attention was about the problems faced by the importers due to the need for nine months before re-registration of the import of drugs. Voicing the members concern he pointed out that it was a little unrealistic and suggested to make it to six months than nine. Arvind Kukreti, assistant drugs controller (India) said that his office will think over the matter after some consideration since its a procedural matter.
It was agreed upon by everyone present that such meeting needs to be organised at least twice a year so that the office bearers can bring in their issues and discuss it with the CDSCO's office and later on these issues can be uploaded on the website for reference.