The All India Chemists and Distributors Federation (AICDF) has urged the union health ministry to expedite the process of modifying the draft guidelines on good distribution practices (GDP) by way of holding talks with the representatives of various trade bodies.

While speaking to Pharmabiz, Joydeep Sarkar, the general secretary of the Federation said that the guidelines have to be made to safeguard the manufacturers in the country but it contains a number of anomalies which require corrections. AICDF has adopted a resolution in this regard and sent to the union health minister for immediate action, he added.

The traders’ body has wanted the health ministry to hold a comparative study of  the proposed GDP draft and the prevailing delivery system in order to understand and locate the basic anomalies in the distribution system. The organisation claims that good distribution practices can be implemented only if necessary measures are taken at the initial stages of the delivery of products. They said GDP should be framed and enforced within the ambit of all the prevailing rules.

The letter addressed to the government states that the draft guidelines are meant to safeguard only the manufacturers and not to provide any benefit to the society. It puts the traders into a quandary by vesting all the responsibilities on the shoulders of the retailers.

Joydeep said that the manufacturers do not provide any directions or guidance regarding transportation and storage of product packs. He alleged that several of the formulations are not packed  as per prescribed norms and not according to the needs of the patients. They are done on a cost-effective manner satisfying largely the business interest. He said this is an unfair practice followed by some manufacturers. There are also evidences of violation of GMP norms by several companies. Therefore while implementing GDP norms it was necessary to have compliance of GMP norms by the manufacturers.

He said that preservation of vaccines and injectables is the responsibility of the traders. But occasional interruption in the supply of electricity puts all the distributors and the retailers in rural areas into serious trouble. Whereas, the manufacturers are enjoying benefit by way of subsidies which traders are deprived of.

The manufacturers often do not adhere to the rules or abide by the instructions of the authorities in properly handling damaged or expired drugs. AICDF wanted the government to initiate strong measures to see that manufacturers are adheres to destruction of expired drugs to stop circulation of misbranded or expired drugs from the market.

The letter further says that current non availability of sufficient number of  qualified pharmacists in the country could make hurdles in implementing the guidelines. Even now only 55 per cent of the available pharmacists are engaged at the community pharmacy services and very few are coming into the trade.