INDIAN PHARMACIST ASSOCIATION

In a special inspection drive launched by the Drugs Control Department of Tamil Nadu in the state’s private blood bank units, the zonal drug officials in Madurai have found that one unit has been working in the city violating various provisions under Drugs & Cosmetics Act for the last ten years.

Soon after the inspection, the unit has been given stop production order by the drug control authorities of Tamil Nadu.

Meanwhile, the regulatory officials in Chennai and Coimbatore have given show causes notices to three other blood banks for not complying with the norms of D&C Act.

State director of drugs control, M Bhaskaran told Pharmabiz that his officials in the Madurai zone have recommended the directorate for cancellation of licence of Vignesh Blood Bank, functioning at K K Nagar. “The unit in Madurai has been functioning without proper infrastructure and equipment. The blood bank was working even without a refrigerator, and the thermograph was found not functioning during inspection,” Bhaskaran said. The Unit has been served a show cause notice for various violations.

In September, the department has launched a special inspection drive across the state following complaints from the public that several of the blood bank units and blood storage centres in the state are not maintaining proper infrastructure facilities. The officials have completed the special inspections on September 30. The state has a total of 260 private blood bank units.

Before the inspection was conducted at Vignesh Blood Bank, it had applied for renewal of licence which was later rejected by the department. The Unit was also given a memo for rejecting the renewal order. As per the norms of D&C Act, each blood bank has to renew its licence in every five years.

According to sources, the CDSCO officials in the state will also conduct a state wide inspection in all the blood banks soon.

To,

The All Medical Superintendents,
Of ESIC Hospitals / Dir(Med) Delhi & Noida,
All SSMCs / SMCs.

Sub:- Regarding temperature maintained in Pharmacy /Pharmacy st9re.

Sir I Madam,

As per Drugs and Cosmetic Act-1948, storage area for medicines should have proper ventilation and should be free from dampness. In schedule P of Drug & cosmetics Act, which deals with life period of drugs, the conditions of storage are as follows»
1. Antibiotics/injections/syrups/vitamins should be stored in a cool place having temperature between 10-25 deg. C.
2. Sera toxins and toxoid, other vaccines, anti-toxins should be stored in cold place i.e. a place having a temperature not exceeding 8 deg. C.
3. Capsules should be kept in a closed container at temperature not exceeding so deg. C.
4. where conditions of storage is not specified, it may be stored under normal room temperature.

Keeping in view the above provisions in drug & cosmetic Act, 1948, it has been decided that to maintain the above temperature the Air Conditioner may be provided in the Pharmacy I Pharmacy stores (where the medicines are stored).

It is therefore, requested to take necessary action.
This issues with the approval of the Medical Commissioner.

Yours Faithfully,

Sd

AKSHAY KALA
Jt. Director (M.A.)

For detailed letter click here

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.