Recent revisions to Schedule M – Oped – Express Pharma Pulse

Recent revisions to Schedule M

The small scale sector being monetarily challenged, the compliance to the revised Schedule M may prove fiscally unfeasible, say Zaina P Qureshi and Dr S S Poddar

George Bernard Shaw once said that, “Some men see things as they are and say, “Why?” I dream of things that never were and say, “Why not?” Our pharmaceutical industry has indeed exploited every opportunity to create and nurture the domestic pharmaceutical manufacturing sector, comparable to any developed nation and it has been their continuous endeavour to better it.

Having said this, the reason they are making headlines again is due to the evolutionary changes made to the Schedule M of the Drugs and Cosmetics Act, 1945. As every amendment faces opposition, it was no surprise this one did too, except, this time around there was a lee way given to the small and medium scale manufacturers of one whole year to comply with the revised Schedule M and rightly so.

There is no denying that the small scale industry has contributed to the Indian pharmaceutical sector in a very substantial way especially relating to the supply of medicines at subsidised rates to government institutions. It is due to these small scale firms that the socio-economically challenged country such as ours is able to sustain a supply of affordable standardised medicines to its population, especially the working middle class and lower class.

Schedule M prescribes Good Manufacturing Practices (GMPs) and requirements of premises, plant and equipment needed to be complied by the manufacturers of drugs during the course of their manufacture or before setting up a new manufacturing unit. These guidelines are essential pre-requisites for maintenance of quality in the production of drugs and pharmaceuticals. Each licensee is required to update these practices through appropriate methodology, systems, procedures, documentation, etc., so as to keep pace with the advances in technology.

The present amendment to Schedule M as per The Ministry of Health and Family Welfare is a progressive mechanism to harmonise the production of drugs and pharmaceuticals and to meet the requirements of international guidelines as recommended by WHO. The often complex issues arising from the implementation of Schedule M have become the primary reason for the overwhelming response to form CIPI (Confederation of Indian Pharmaceutical Industry), the national level body set up by the industry to look into the detailed implementation of Schedule M in detail.

The revised Schedule M incorporates specific requirements for production of different pharmaceutical dosage forms, which include IV fluids, ophthalmic preparations, solid dosage formulations (tablets and capsules), bulk drugs, etc. The requirements of plant and equipment and the minimum areas of premises for the dosage forms have also been revised.

A minimum ancillary area (approximately 10 sq.m.) for basic installation has also been incorporated for each functional component of manufacturing process to accommodate associated activities.

The revised Schedule M also envisages the requirements for documentation at every stage of production, validation of processes and equipment; efficient Standard Operating Procedures (SOP) relevant to different stages of manufacture and quality control operations; training of technical personnel engaged in the manufacture and testing.

Also the concept of self-inspection and preparation of Site Master File containing factual information on GMPs observed in connection with production and QC activities carried out by the licensee. Though such a statutory intervention was necessary as many of the drug units in the country are operating in sub-standard manufacturing environments producing sub-standard products, these stringent specifications laid down to ascertain the quality of pharmaceuticals in the new GMP rules under Schedule M of Drugs and Cosmetics Act could make life difficult for the average small or medium scale manufacturer.

The small scale sector being monetarily challenged, the compliance to the revised Schedule M may prove fiscally unfeasible. Investment as well as the employment of time and effort in such an attempt would mean a shoot up in drug prices, a major blow to an industry which has made inroads in the global market due to its price competitiveness.

The main cause for concern in case of the small scale producers are issues like the lack of space, maintenance of state-of-the-art equipment, lack of trained professionals for the usage and maintenance of such equipment, the increase in cost for employing such labor and many more. Per unit investment would be in crores, presumably proving to be a handicap to the manufacturers. It does seem unreasonable to expect such changes to emerge for some time.

In view of these facts, The Ministry of Health and Family Welfare decided the cut off date in case of manufacturers existing as on 11.12.2001 which was 31.12.2003 as per notification GSR 894(E) dated 11.12.2001, to be extended by one year, to 31.12.2004. The provisions of the revised Schedule M will be made applicable with effect from January 01, 2005 in case of manufacturers licensed prior to 11.12.2001.

Though the CIPI is in complete agreement with the implementation of the revised Schedule M, they do have concerns regarding the immediate deadline posed by the Ministry. As a result the CIPI aims to request the government to give an extension of time on the proposed deadline for implementation of the new amendment, to avoid a hasty decision, which may have adverse effects in the long run.

Should the industry be given more time to comply? Considering the costs involved and inevitability of implementation of the amendments, is it really enough time for the industry to come up with an innovative solution or merely delay the inevitable?

The writers are with Prin. K M Kundnani College of Pharmacy, Mumbai