The Drugs Controller General of India's (DCGI's) office is preparing a document in a bid to lay down a system to follow while granting marketing approvals. The step is to address the issue of patent linkage between the drug regulatory authority and the Indian patent office.
Once prepared, the document will be made available for the industry for discussion and the authority will ensure protection of interests of the pharmaceutical industry, according to Dr Surinder Singh, DCGI. The document is expected to address the hot issues related to the non linkage between the DCGI's office and the patent office, which has much concerned the foreign innovator companies and the Indian generic companies.
Delivering key note address in a seminar, 'How Quality Pays', conducted by Indian Drug Manufacturers' Association (IDMA), the DCGI said that the Indian pharmaceutical industry is going through a changing scenario and has to meet various challenges. The linkage between patent office and drug regulatory office is one among them which does not have a system to solve mutually at present.
"We should consider that the Indian pharma industry has come a long way ahead over the past few years and the companies were using the patent advantage for generic growth. The document we are preparing, will address the issue with patent office without compromising the interest of the Indian companies and the public," he averred.
The Central Drugs Standard Control Organization (CDSCO) is currently, developing a system for its operations and the primary focus is to bring in Standard Operation Procedures (SOPs), guidance documents and specific time frame for clearance of files. In order to modernise the operations of the organisation, an e-governance project has been designed. With this, the records in the drug regulatory system will be digitalised and an interactive portal will be launched for better communication between the organisation and the industry players from various parts of the country, said Dr Singh.
"The e-governance method will ensure transparency and accountability in the regulatory system. With our stronghold in IT, the people will be trained to get their needs done from CDSCO using the e-governance," he maintained. He also added that the industry should come forward to communicate its complaints, suggestions and ideas with the drug control mechanism in future.
Speaking on his experience with the quality assurance methods, N H Israni, chairman, Blue Cross Laboratories Ltd suggested that the industry must keep better quality on products, keeping the health of its consumer on view. In the last two decades, the Indian pharma industry has changed dramatically and the emerging global scenario demands best quality drugs for public health.
The industry has to consider the containment safety of workmen as a major issue, even as the effect of chemicals on the human body is not taken much into consideration by the Indian pharmaceutical companies at present, said Ajith Singh, chairman, ACG Worldwide. Sharing his experience on the quality assurance methods implemented in his company, he added that the industry should think about low cost techniques to fight against spurious and counterfeit drugs.
While the welcome address was delivered by B N Singh, president, IDMA, J L Sipahimalani, chairman, Quality Management Sub Committee of IDMA has delivered the opening remarks and the vote of thanks. Eminent speakers including Dr Venugopal Somani, Deputy Drugs Controller of India (West Zone), Prof Saranjit Singh, professor and head, Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), S M Mudda, executive director - Technical and Operations, Micro Labs Ltd and Gidy Asrani, a pharmaceutical consultant, shared their views on specific quality assurance methods and regulatory requirements.