Synopsis on the Draft Amendment to the New Drugs and Clinical Trials Rules, 2019

The Ministry of Health and Family Welfare has notified Amendments to the New Drugs and Clinical Trial Rules, 2019 (“Rules”).

A. Manufacture of new drug for Compassionate use

1.   Manufacturer who intends to manufacture new drug for Compassionate use shall obtain a written consent from the patients and make an application to the Ethics Committee for obtaining its specific recommendation for manufacture of new drug for Compassionate use. Once the recommendation is obtained, manufacturer shall make an application to the Central Licensing Authority (“Authority”) to grant permission for manufacturing of new drug.

2.   The permission granted shall be subject to the following conditions :

• The permission shall remain valid for a period of one year;
• The new drug can be used on the concerned patient under the supervision of the medical officer
•  Manufacturer shall make use of the new drug only for the purposes specified in the permission and no part of it shall be sold in the market;
• The new drug has to be stored under proper storage conditions;
• Manufacturer should maintain a record and submit quarterly report on the status of the new drug manufactured to the central government; and
•  Inform the Authority of the occurrence of any serious adverse event and action of recall will be taken by Authority within 15 days.

B. Import of unapproved new drug for Compassionate use :

1.   A hospital or Medical Institution may import new drug by making an application to the Central Licensing Authority (“Authority”) for the treatment of patients suffering from life threatening  disease or disease causing permanent disability.

2.     The import licence granted, shall be subject to the following conditions,

• The licence shall be  valid for a period of one year;
•  The licence should  be displayed in the premises;
•  Imported new drug has to be stored under proper storage conditions;
•  New drug shall be exclusively used for compassionate use;
•  Importer should submit quarterly report on the usage of the new drug to the central government; and
• Further, the importer should maintain the records of the left over or unused or expired or damaged or sub-standard quality of new drug.

Compassionate use means use of new drug, which has not been permitted in the country under Chapter X of the Rules, but under Phase-III clinical trial in the country or in any other country, for diagnosis, treatment, mitigation or prevention any life threatening disease or disease causing serious permanent disability or disease requiring therapy for unmet medical need under a treatment protocol.

Article contributed by Surekha Rao and Shamile Haridevan from Triangulas