The Pharma Gladiator, an NGO working in the health sector, has termed the issuance of draft guidelines on guidelines on Good Distribution Practice (GDP) by the Drugs Controller General of India (DCGI) recently as illegal and non-implementable at its present form.

In its suggestions to the DCGI on the guidelines, the NGO said that DCGI does not have the legal authorisation to announce such guidelines as they are not in line with the various provisions of the Drugs and Cosmetics Act (D&C Act). The D&C Act shall always prevail as the statutory guideline. The announced guideline in a way is an attempt without proper authorisation to surpass the various provisions of the Act by back door.

The proposed guidelines are in the form of pre guideline document. It has not considered the present distribution system. In fact, there is no systematic study done on the present distribution system in place. The state drug controllers have not been asked about the system operational in their states. It is necessary all the state unit of CDSCO and the state drugs control organisation shall be asked to do independently the systemic study of the present system of distribution existing in their territory with regard to its efficiency and need to deal with quality distribution system.

“The guidelines are being pushed in haste without giving the statutory time limit and therefore it creates the suspicion in the minds of transparent people.  It is surprising all of a sudden somebody find everything in the present system bad and come out with the guideline which are difficult to understand and implement. It is full of heave word and terminology which cannot be understood by the people who are in distribution chain at present. We request you not to enforce and publish these guidelines as it is, Pharma Gladiator's chief trustee Narendra Jain said in the letter to the DCGI.

Posing several questions on the guidelines, the letter asked, Will there be any need to retain the present Rule 65 if the proposed guideline comes in place?   Will there be any need for section 19 if the present guidelines become operational?. Is the present guideline aims to replace the 7.5 retailers and equal number of wholesalers from the distribution channels?

Earlier, the DCGI had issued draft Guidelines on GDP for pharmaceutical products to ensure the quality and identity of pharmaceutical products during all aspects of the distribution, and had sought objections and suggestions from the experts and public.