Despite the initial hue and cry over the implementation of the revised norms for good manufacturing practices (GMP) in the country, the Indian pharmaceutical companies are now aggressively embracing the standards set by the drug regulatory authority. More companies are hastening their upgradation process to comply with the standardised norms under revised Schedule M and an increase in number of companies getting GMP certification from the state drug control offices throughout the country points to the current trend.
Several of the state drug regulatory authorities in the country are currently on the final stages of implementation of the revised Schedule M. For instance, Maharashtra, one of the major pharma hub with around 1007 pharma units, including domestic pharma leaders like Cipla Ltd, Sun Pharmaceuticals Ltd, Wockhardt, Glenmark, apart from several multi national pharma giants like Pfizer, Wyeth and GlaxoSmithKline (GSK), has announced a GMP compliance of 73 per cent in the state till May 2008. However, some states like Gujarat claims cent per cent GMP compliance.
A sudden surge in compliance with revised Schedule M has been reported by the state Food and Drugs Administration (FDA) in last one year, as the authority has issued license to almost 109 units in the state between April 2007 and May 2008. Till April 2007, out of the total 1007 units 622 units were complied with the revised Schedule M standards, while the license of 162 units were cancelled by FDA. Currently, the FDA report shows that almost 251 licenses were cancelled due to non-compliance of GMP standards.
Further, 25 units are under technological upgradation process and their manufacturing activities were stopped for the time being. However, many of these companies have partially complied with the standards for which the manufacturing approval has been allowed, according to FDA officials.
"Several of these companies have complied with the norms in some of their divisions and we are considering it as partially complied units. The divisions, which adhere to the standards, are allowed to manufacture products. These units can apply for fresh license once the whole upgradation process is completed. We have not fixed any time limit for this," said a senior FDA official. Many of the companies, which are under upgradation, are manufacturing products like petroleum jelly that plays lesser role in pharmaceutical products.
Initially, when the revised standards were mandated in July 2005, the small scale pharma companies with local and limited operations were worried about the expense to be made over technology upgradation. The industry representatives from associations like the Confederation of Indian Pharmaceutical Industry (CIPI) asked concessions for the small scale industry to install Air Handling Units (AHUs), which were then, had a cost between Rs 2.5 lakh and Rs 3 lakh.
Some of the districts in Maharashtra, which were rich with presence of pharmaceutical companies had faced a heavy loss in unit strength after the implementation of the latest GMP standards, reveals the official records. For instance, the total number of units in Mumbai decreased from 150 to 80, as the rest of the 70 units were closed down due to non compliance of quality manufacturing standards.
"Complying with the revised Schedule M has a lot to do with the overall renovation of the manufacturing unit, as many of the companies were operating in limited space with few options for expansion. Many of them had to relocate the unit, which demanded a higher investment to continue their operations," said, B E Khomne, assistant commissioner (rtd) with the WHO-GMP cell of Maharashtra FDA. "The companies had to spend a minimum of Rs 25 lakhs to get the plants upgraded as per the revised norms," he added.
"The rules like installing hepafiltration facilities and graft ventilation need high investment by the companies. Overall, ducting of the plant, in connection to the setting up of facilities like AHUs are of high cost and the regulators has to go through each and every details and documents at the time of inspection," said a source from FDA. However, the main attraction of getting upgraded with the mandatory GMP standards will benefit the companies in international operations, as the revised Schedule M standards are on par with the World Health Organisation's (WHO) GMP.
"The parameters mentioned for licensing under Schedule M are similar to that of WHO GMP, except the nomenclatures. But many of the companies are not opting for the WHO certification, as it is not mandatory for companies as in the case of Schedule M but voluntary," averred Khomne. The task of the regulator is primarily to be vigilant on the final quality and general environment of the manufacturing plant before signing an approval.
The plants, which have already certified as GMP complied, are also going through the annual inspection from the regulatory office, as the revised Schedule M insists at least one inspection in a year from the state drug regulatory office to each manufacturing plants. The officials opined that the companies can maintain the standards as per the requirement once they qualify GMP norms. If the authority identifies lack of quality as per the norms in the annual inspection, the unit will have to face suspension or cancellation of license immediately, added the source.
However, the industry sources reveal that in spite of its apprehensions among the players about a massive closure of small scale companies, the revised schedule M has opened up an opportunity for these players to expand their export operations to more countries. "Considering the mandatory norms in India are almost equal to WHO standards, the small scale companies which have complied with the Schedule M can go for WHO certification, which will help expand its operations to various countries," said an industry source.