Updated on 27 September 2012
What do pharma firms do to get regulatory approvals in India?
The domain of life sciences in the Asia Pacific (APAC) region provides several opportunities for organizations that are seeking to grow in the region. Regulatory approvals often emerge as a hindrance for these firms in the APAC region. BioSpectrum speaks to industry individuals and regulatory professionals from India, in order to compile a guide on the regulatory processes in the largest democracy of the world. (Also read this week: Regulatory requirements in China, Taiwan, Australia, Hong Kong, Indonesia, Singapore and Korea)
In India, an applicant is required to file application in Form 44 along with prescribed fees in the form of treasury Challan and all relevant data as per Schedule Y to Drugs and Cosmetics Rules, for seeking permission to import or manufacture of new drug substances and its formulations for marketing in the country. The documents include chemical and pharmaceutical information, animal pharmacological and toxicological data, clinical data of safety and efficacy regulatory status in other countries etc and results of clinical trials on local population.
In case of new drugs approved in other countries, the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such a nature that the licensing authority may, in public interest, decide to grant such permission on the basis of data available from other countries. The submission of requirements relating to animal toxicology, reproduction studies, teratogenic studies, perinatal studies, mutagenicity and carcinogenicity data may be modified or relaxed in case of new drugs approved and marketed for several years in other countries and adequate published evidence regarding the safety of the drug is available.
Although, Drugs and Cosmetics Rules does not specifically mention about the period of marketing of a new drug in other countries, which can be considered as "several years", it is necessary that for relaxation or modification of the animal toxicology data requirements of a new drug as mentioned above, the drug should be marketed in other countries for a period of more than two years and adequate evidence regarding safety of the drug in published journals should be made available to Central Drugs Standard Control Organization (CDSCO). Such relaxation or modification of requirement of toxicological data will be considered by CDSCO on case-by-case basis in consultation with experts or expert committee.
As per Clause 1(3) of Schedule Y to Drugs and Cosmetics Rules, for drugs indicated in life threatening or serious diseases or diseases of special relevance to the Indian health scenario, the toxicological and clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the licensing authority. There is as such neither any definition of "life threatening or serious diseases" nor any list of such disease or disorders prescribed under the Drugs and Cosmetics Act & Rules. "Life-threatening" diseases are generally considered as diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes. Diseases such as cancer and AIDS are generally considered as serious or life threatening diseases.