Drugs Controller General of India (DCGI) will be setting up a  committee to oversee the formulation of guidelines for the Good Distribution Practices(GDP). The  decision was taken at a recently held meeting  state drugs controllers.

Although the agenda was to discuss the regulations in medical devices, clinical trials  and fixed drug combinations, the focus of the meet was  on the need to amend the Drugs and Cosmetics Act with the addition of new schedule on Good Distribution Practices.

Pharmabiz had earlier reported that Karnataka Drugs Controller Dr BR Jagashetty was mandating the need for a dedicated guideline for good distribution practices. Now the DCGI has consented for formulation of a specific guideline that would  insist on recall, discard  and destroy of date expired drugs, substandard and defective packaged products.

Dr Jagashetty had put forward the recommendations that the Drugs & Cosmetics Act should be amended to allow the recall of expiry dated, not-of-standard quality and defective packaging products. In this regard, he had been insisting for the inclusion of a new Schedule to facilitate the instant recall of  drugs that are found not fit  for sale,  prescription and use.  

In Karnataka, under the reign of Dr. Jagashetty, regular and surprise inspections are being carried out. Going by the presence of the expiry dated drugs which were not recalled by the pharma companies and found to be stored in the chemist outlets, he mandated a regulation which would make the manufacturers do the needful on the same.

The key objective of the guidelines on the Good Distribution Practices would prevent the movement of such drugs including  substandard drugs declared because of poor storage conditions and faulty packaging, stated Dr Jagashetty.

The focus of the guidelines should be to recall the drug by the pharma companies from the pharmacies. “It is high time the companies take on the onus for this because the retail outlets have no role to play in the case of substandard and expiry  dated medicines,” he said.

Therefore pharma companies should gear up to make concerted attempts to withdraw such  drugs within  48 hours to a week. In addition, the guideline will also look at making the manufacturer accountable for the drug once its leaves his packaging centre. “The drug supplies  should be closely tracked by the manufacturer not only till the retail outlet but keep tabs on its sales and its   storage is ensured in an appropriate manner at the retail outlets which is also a key component of the guidelines for good distribution practices,” he said.

The guidelines are being formulated to safeguard the patients. This where we are working to include GDP as a  separate Schedule in the  clause in the Act. There would also be a mention that if the drug is not recalled within the  stipulated time frame, then it would become a punishable offence, said Dr Jagashetty.

“The attention to GDP will help solve at least 60 per cent of the issues in the pharmacy sales. When India is being recognized for its high quality drug production, GDP should be an important part of the guidelines. Globally, the practice of recall is stipulated. Therefore the  Indian drug regulatory authority  should also ensure its implementation  at a fast pace,” stated Dr Jagashetty.