The Ministry of Health and Family Welfare is working on a Common Technical Document (CTD) format for the pharmaceutical industry. The CTD format will be useful for companies preparing dossiers for product approvals in the country, in lines with the CTDs in developed countries.

With the introduction of CTD, the pharmaceutical companies have to prepare dossiers for any approval from the Central Drugs Standard Control Organisation (CDSCO) with standards set for various countries under the International Conference on Harmonisation (ICH) guidelines.

The CDSCO is preparing the document for implementing the system with the support of the US Food and Drug Administration (FDA), the National Health Surveillance Agency (Anvisa) and various other regulatory authorities, according to Debashish Panda, joint secretary, Ministry of Health and Family Welfare.

"The implementation of document will help the companies when they apply for approvals in other countries, especially in the developed countries. We will ask for precise dossier preparation for approvals, once the CTD is implemented. The ministry is planning to introduce the common documentation format in vaccine manufacturing segment as a pilot project in the next few months," said Panda.

"The format will seek all the documents related to the manufactured vaccine in lines with the ICH guideline. The vaccine segment will be the testing lab for the implementation of the policies to the other pharmaceutical sectors," said Surinder Singh, drug controller general of India (DCGI).

Implementation of new document format is one among the ministry's project to refine the regulatory standards of pharmaceutics in the country. The ministry and CDSCO is working closely with the regulatory authorities like the US Food and Drug Administration (FDA), the National Health Surveillance Agency (Anvisa), Brazil and the Canadian regulatory agency - Health Canada - to betterment the drug regulatory mechanism in the country.