The central government is planning to come out with changes to the revised Good Manufacturing Practices (GMP) norms that are to be in force with effect from January 1, 2004. The fresh amendments to the new Schedule M of the Drugs and Cosmetics Rules 1945 would consider most of the minor changes suggested by the drug industry. A notification announcing the changes is in the offing, it is learnt.

According to sources, the changes are to be more of a cosmetic nature, with better phrases, clearer definitions replacing the original versions in several areas. Among the changes agreed by the Central Drugs Standard Control Organisation (CDSCO), the provision to carry out manufacturing of contamination causing and potent products on a campaign basis is to prove to be of help to the small scale drug manufacturing sector. The revised Schedule M says that “to avoid the risk of cross-contamination, separate, dedicated and self-contained facilities shall be made available for the production of sensitive pharmaceutical products like penicillin or biological preparations with live micro-organisms and separate dedicated facilities shall be provided for the manufacture of contamination causing and potent products such as beta lactum, sex hormones and cytotoxic substances”.

The amendment would bring in an addition to the sentence to say: “The manufacturing of these may be carried out on campaign basis, subject to proper cleaning and validation of the cleaning process”.

The major plea of the industry that would not be accepted by the CDSCO is known to be their request for the shelf life of a formulation exceeding the shelf life of constituent active ingredients.

The minor changes to be carried out in different sub-clauses of the Schedule M would moreover be like the following: “water” replaced with “purified water”, “product” with “material”, “samples” with “samples of packaging materials”, “ bulk” with “ bulk of packaging materials” etc.

The SSIs had been against the clause, which asks for the maintenance of “records for distribution in a manner such that finished batch of a drug can be traced to the retail level to facilitate prompt and complete recall of the batch, if necessary”. It is known that the CDSCO has agreed to change the sentence to “records for distribution shall be maintained in a manner to facilitate and complete recall of the batch”, thereby avoiding the mention of the level upto which the company needs to maintain the records.

Another interesting request from the small-scale pharma sector was to make it mandatory for the regulatory bodies or government bodies to train the industry personnel to meet the advanced and sophisticated requirements. The CDSCO has chosen to ignore the request, as it doesn’t come within its primary functions.

The decision to bring in amendments to Schedule M was taken during an interaction with the Union Health Secretary and the industry associations some time back. The CDSCO had been studying each plea for its merit and as the final step had forwarded its views to the Drugs Technical Advisory Board.