The Hindu Business Line : Govt scrutiny of new drugs to be more stringent

The Government plans to strengthen the post-marketing surveillance system whereby companies would have to submit Periodic Safety Update Reports (PSURs) every six months for the first two years after approval for a new drug is granted.

"So far the rules stipulated that an importer or manufacturer of a new drug would conduct surveillance study during the initial two years of marketing. But now, they will have to do so after every six months for the first two years. For the subsequent two years, PSURs need to be submitted annually," said Ministry sources.

This is likely to be part of the revisions to Schedule Y of the Drugs and Cosmetics Rules, 1945, which deals with norms for clinical trials and a notification is expected shortly.

The Government is also keeping the option of allowing the Drug Controller General of India or the licensing authority to extend the total duration of submission of PSURs if it is considered necessary in the interest of public health.

It has further proposed that all cases involving serious unexpected adverse reactions must be reported to the licensing authority within 15 days of the initial receipt of information by the applicant.

The drug companies would have to report all the relevant new information from appropriate sources, relate these data to patient exposure, summarise the market authorisation status in different countries and any significant variations related to safety and indicate whether changes should be made in product information in order to optimise the use of the product.

"All the dosage forms and formulations as well indications for new drugs should be covered in one PSUR. Even new studies planned or conducted to examine a safety issue should be described in the report," they said.

Besides these reports, the Health Ministry is also planning to change the prescribing information or package inserts. It has sought to provide exhaustive information on generic name, composition, dosage forms, shelf-life, use in special populations (like geriatric patients, paediatrics, lactating mothers) besides contra-indications, warnings, and undesirable effects.

The Government decision to tighten post-marketing surveillance studies comes at a time when Merck voluntarily withdrew an anti-arthritis drug, Vioxx (generic: rofecoxib), due to side effects. Subsequently, the entire class of drugs or Cox-2 inhibitors have come under the scanner not only in international markets but also in India.

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