IP can be claimed for standard strengths of dosage forms, not for altered strengths: IPC

In an effort to strictly adhere to the drug regulations and to improve the quality of medicines by having a control on the dose metrics, the Indian Pharmacopoeia Commission (IPC) has clarified to the industry that only the drugs of strengths prescribed in the previous edition of Indian Pharmacopoeia (IP) or recommended by the drug regulatory bodies could claim IP - 2010 standard for dosages.
The additions made in the latest volume of IP are based on usual strength as available in the previous edition of IP or other current pharmacopoeias, usual strength available from the inputs given by the regulatory bodies including the recent updates in dose metrics from the Drug Controller General of India (DCGI) and with the inputs given by industries, clarifies the commission.
The move is expected to indirectly control the dose metrics to improve quality of medicines marketed in India, according to a senior official from IPC. The clarification of IPC that it intends usual strength of medicines when IP standards are concerned, is expected to gradually make the companies stick on to the usual strengths rather than introducing new strengths of medicines which requires clinical investigation to prove the safety and efficacy prior to marketing.