While the deadline for the Schedule M compliance is fast approaching within four months, the small-scale sector pharmaceutical manufacturers in the country are worried over the delay on the part of the Central Government to notify the proposed dilutions in Schedule M even after eight months since the announcement.
According to informed sources, the decision is still pending with the office of the Union Ministry of Health and Family Welfare, and they are not sure when or whether the Health Minister will sign the order. At a recent interaction with the leadership of the Confederation of Indian Pharmaceutical Industries (CIPI) in Delhi, the SSI industry representatives had brought this also to the attention of the minister, who in turn, had assured to do the needful.
It may be noted that while extending the deadline for Schedule M by one year in the last minute during the last week of December, last year, the then Union Minister of Health and Family Welfare Sushma Swaraj and the DCGI had assured the industry representative to dilute certain clauses in the Schedule M to considerably reduce the investment burden of SSIs.
The proposed clauses include dilution of norms related to setting up of mandatory air-handling facilities in production and storage, ancillary area specifications like requirement of area for tableting, capsuling and punching, mandatory quality control equipments etc.
The ancillary area specifications for each and every unit will require more additional space for most of the units, especially for units located in prime areas of cities. One among the assurances was to dilute mandatory specifications related to ancillary areas for various sections.
Similarly, the current Schedule M mandate include Humidity Ventilation and Air-conditioning (HVLC) for the entire manufacturing area which mandates to have air-conditioning systems in most of the areas and setting up of ducts, absolute filters, blowers, air-positive pressure systems etc.
During the discussions, the officials and minister had agreed to change HVLC condition as 'controlled air', which will help to reduce investment in areas like warehouses, where blowers or exhaust fans could be fitted instead of virtually air-conditioning the premises.
The Government also had agreed to do away with a few provisions related to mandatory quality control equipments like HPLC machines. It was brought to the notice of the authorities that such a machine has capacity to the tune of testing about 500 samples per day and costs about Rs 7 lakhs, and is not required for an SSI drug unit, which usually tests only about 10 samples per day. Numerous high quality laboratories with advanced infrastructure are available in most of the pharma hubs in the country, and the industry could outsource their services as done so far, industry had informed the authorities. The authorities also had agreed to favourably consider this, though an assurance was not given in the case of HPLC machines.
Sources say the delay in notification has caused stalemate among many manufacturers to go for Schedule M modernization, and are following a wait and watch policy anticipating the Government notification on dilutions.