Monday, August 8, 2011

FGSCDA urges govt to amend D&C Act to disallow strip cutting

The chemists and the druggists in Gujarat have demanded to the government to make necessary amendments in Schedule P with regard to cut strips in the Drugs and Cosmetics (D&C) Act to ensure uniform strip size for all the drugs.

In a representation to the commissioner of Food and Drugs Control Administration (FDCA), the Federation of Gujarat State Chemist & Druggist Association (FGSCDA) urged the government to amend the Drugs and Cosmetics (D&C) Act and demanded that no strips size beyond ten, six, four or two should be permitted.

“There should not be more than 10 tablets or capsules per strip as the present strip size of 12 and above are either cumbersome to handle or they have to be cut to suite the budget of the patients,” reads the representation. Jashvant Patel, president, FGSCDA pointed out that this issue needs to be addressed urgently as cut strips is one of the causes for development of antimicrobial resistance as it leads to under dose of the antibiotics in patients.

Only about 1 per cent of the drugs in the market today are governed by mandatory pack size fixation. As of now D&C Act is silent on whether a strip can or should be cut or not which causes lot of confusion as different drug control authorities give different interpretations of this.

According to Patel, “We need more transparency in this matter as strip cutting is a serious problem which the lawmakers, FDA officials, pharma industry or the doctors cannot understand. It is finally the customers and the retail pharmacists who have to face the brunt of the losses and risk of consuming the wrong or expired medicines. Thus it is imperative that the government should take some steps to solve this problem so as to deal with the shortcomings of the present system of the pack sizes and problem of strip cuttings.”

For all the retail chemists, strip cutting is a huge problem that needs to be addressed urgently as it comes with heavy loss. Cut tablets are often difficult to be identified since the name of the drug may not appear on every part of the strip or foil and as embossing on the tablet is not always identifiable it is a potential loss to the chemist.

Patel further pointed out that adding to all these problems is the fact that cut strips which have expired are not settled by stockists and manufacturers thus putting the pharmacist at loss.

The association in its representation proposed certain suggestions to the government, which they expect to be amended in the Schedule P of the D&C Act. “Pro active steps should be initiated to ensure that strip cutting is disallowed completely as it will ensure that no physician samples or expired drugs with no batch number or expiry details are pushed forward to the patients,” he added.