An extension of the deadline for Schedule M implementation to be announced early next week may incorporate stringent and elaborate provisions for Standard Operating Procedures (SOP) for SSI drug manufacturing units as applicable to all drug-manufacturing units.
Though the revised Schedule M norms had mentioned the SOP, it had not specifically elaborated the details of documentation required by SSIs. The new recommendations are mainly to ensure maintaining proper records on Quality Assurance (QA) and Quality Control (QC), so far normally followed only by large-scale drug units.
If implemented, each of the SSI drug-manufacturing units will have to maintain a series of records, besides employing a minimum of two qualified pharmacists. As per the recommendations, every manufacturer will have to keep each batch records, which will daily work out to at least 56 pages instead of a simple two-page format currently in practice. Further, records have to be maintained on every product, each of the validations, machine and processes. Data loggers (test results kept in a print out format) also will be mandatory. Maintenance of records on calibration and validation will be necessary. Records have to be maintained on quality assurance and quality control.
It is estimated that this may amount to an additional spending of at least Rs.20, 000 per month on the part of all the units. At present most of the units maintain only the required registers of transactions, production etc. as per the rules applicable to SSI units. Sources note it may require the services of at least two skilled pharmacists in a unit to maintain the records as specified in the recommendations, instead of the present system maintained normally by one or two clerical staff.
Informed sources told Pharmabiz.com that this has been included by the Drug Controller General of India (DCGI) in his report submitted on Friday to Sushma Swaraj, Union Minister for Health and Family Welfare. Two days ago, the minister had asked the DCGI for a hasty report on the changes incorporated in the Schedule M notification in 2004 in comparison to the norms announced in 1987, besides suggestions on further extension of revised schedule M norms.
It is learnt that the recommendation is to implement this within a timeframe of one year.
When contacted, industry sources said the drug industry associations would vehemently oppose the move, if the government decides to go ahead with the decision. They fear it would open up avenues for the drug enforcing agencies to unnecessarily harass and punish the small-scale sector units. Besides, additional expenditure to the tune of Rs.20, 000 per month is an exorbitant amount for the SSI units, most of them going through a poor run in business due to various factors.
"While we talk of reducing the paper work, this move will cause thousand fold increase in paperwork for the SSI units. We don't understand the need for such huge paperwork in a small unit, which produce very less everyday in comparison to big units," said a source.
However, a section of the SSI industry leaders feel the strategy should be to first get the extension and then oppose the move on documentation. Sources said the ministry might come up with a decision by early next week and most probably, the extension would be for two years.