INDIAN PHARMACIST ASSOCIATION

The Indian Pharmacy Graduates Association (IPGA) has put up a demand with the Drug Controller General of India (DCGI) to amend the relevant provisions in the Drugs & Cosmetics Act and the Rules thereunder to mandate that only qualified registered pharmacists should be eligible for getting wholesale licence of pharmaceuticals.

At present, under the Rule 64 of the D&C Rules, 1945, the eligibility condition for issuance of wholesale licence for drugs is that a competent person, who is a registered pharmacists or who has passed the matriculation examination or its equivalent with four years experience in dealing with drugs or who holds a degree of a recognised University with one year’s experience in dealing with drugs should be in charge of the premises.

The Association argues that this leaves a quality gap in the drug distribution chain, as the competency of person involved in manufacturing is mandated to people completed science or pharmacy education and the retail licences are issued only to qualified pharmacists.

The rule was made long back, in 1945, when there were less pharmacy professionals but the scenario has changed now with more than 10,000 students completing pharmacy courses every year from almost 750 pharmacy colleges for graduation and more than 250 colleges for post graduate pharmacy courses at present, says Atul Kumar Nasa, president, IPGA.

“Since any lacuna in handling of medicines at wholesale stores can adversely affect the delivery of medicines, the D&C Act is required to be amended on urgent basis so that at all levels medicines are handled by qualified registered pharmacists only. We have raised the issue with the DCGI. The DCGI has assured that the issue will be taken up for discussion in the next DCC (Drug Consultative Committee) meeting,” said Nasa.

Similarly, the rules under the D&C Act specifying the qualification of professionals in manufacturing sites should also be amended giving due prominence to the qualified pharmacists. Pharmacists, who have completed diploma, degree or post graduate courses in pharmacy, are technically the eligible persons to handle drugs, he added.

The All India Drug Control Officers’ Confederation (AIDCOC), the organisation of drug control officers in the country, has also moved the demand to the DCGI, said Nasa, who is also the vice-president with the AIDCOC.