The union health ministry may go in for a revision of the Schedule P of the Drugs and Cosmetics (D&C) Act in view of the changes in the pharmaceutical industry in recent times and to include new drugs which had been permitted for manufacturing and marketing in the country.
The Central Drugs Standard Control Organisation (CDSCO) may set up an expert panel in this regard to suggest recommendations in tune with the times for amending the Schedule P which lays down the storage conditions and life period of drugs.
As of now, many drugs like meropenem, imipenem, feropenem, moxifloxacin, vancomycin, cefipime, cefpirone ceftazidime, cefuroxime etc. were not included in the Schedule P as no fresh amendment was done in the recent past.
The matter had come up at the meeting of the Drugs Consultative Committee (DCC) also recently and it gave a go-ahead to the proposal, considering the changes in the industry and the difficulties faced by the regulatory officials, sources said.
The Schedule P at present has specified storage conditions for 85 antibiotics, 27 vitamins, five insulin preparations, seven normal human plasma, 19 sera toxin and toxoid formulations, 16 vaccines, antitoxin, etc.
The proposed revision of the Schedule P may also look into other demands by the chemists bodies in the past and hold consultations with the stakeholders. One of the demands raised by the druggist associations is the amendment to disallow strip cutting beyond 10, 6, 4 or 2.
According to them, this amendment would ensure the imposition of a uniform strip size for all drugs. They also suggested that there should not be more than ten tablets or capsules in one strip, as it is difficult for many patients to pay for the present strip size of 12 and above. At present, only one per cent drugs are following pack size fixations norms. While, different drug control authorities have their own interpretations on strip cutting issue.