Govt Move To Amend Schedule M Of D n C Act Leaves Industry Jittery

New Delhi, 31 Oct 2018: The Union health ministry’s move to revise regulations pertaining to manufacturing practices under Schedule M of the Drugs and Cosmetics Rules, 1945 has left the domestic drug manufacturing sector in a quandary. Firms have to shell out exorbitant amounts of money to implement the revised Schedule M norms, which would prove a drag on the sector already troubled by steep rise in active pharmaceuticals ingredient (API) costs. 

The ministry had floated a draft proposal to amend the D&C Rules to modify Schedule M for making it on par with WHO-GMP standards.

The proposal has come as no surprise as the government is getting ready to implement uniform standards for drug manufacturing industry ahead of joining the Pharmaceutical Inspection Cooperation Scheme (PICS), a global mechanism to improve cooperation in GMPs between regulators. At present, while majority of small and medium manufacturers in India comply with Schedule M, only around 20 per cent of the firms meet WHO GMP norms, leading to dual standards of quality. 

According to industry sources, if amended rules of Schedule M come into force, each drug manufacturing firm will have to shell out up to Rs. 6 crore, which could sound the death knell for many small firms surviving on wafer-thin profits. “This is a very serious issue. If not addressed now, it will lead to disaster. Implementing these provisions will be suicidal for many small firms. Revised Schedule M is a must for exports, but existing GMP is more than sufficient for local marketing. It is true that there are a few manufacturers who flout rules, against whom the authorities have to take action. But majority of manufacturers are doing business with the best resources available. In fact, implementing revised Schedule M is not possible for most micro, small and medium enterprises as its cost, considering infrastructure requirements, is exorbitant,” Sanjiv Rai, president of Bihar Drugs and Pharmaceutical Manufacturers’ Association, told Pharmabiz. 

The government has left the draft proposal open for inputs from stakeholders till November 5. But industry stakeholders are seeking more time to submit their suggestions, considering “the path-breaking nature of changes” proposed in the draft amendment. “Our team is still studying the extensive draft notification. We are asking for 90 days’ time to give our comments,” Federation of Pharma Entrepreneurs (Fope) president BR Sikri said. 

In its letter to the ministry on October 30, a copy of which has been reviewed by Pharmabiz, the federation stated: “We have received a number of representations from our members stating that 30 days period given in the said notification for submission of suggestions /objections is not sufficient taking into consideration massive changes contained in about 150 pages of the notification consisting of numerous clauses and sub clauses which are to be assessed and implications to be examined.” 

“The fact is that proposed changes are to be studied by QC/QA and Regulatory Affairs departments for inputs before a clause-to-clause detailed submission is made for which sufficient time is required,” the industry lobby group added in the letter. 

Regulatory experts also point out that the implementation of new GMP is not a guarantee for quality medicines. Moreover, it would increase production cost substantially, which could eventually lead to drug price rise. 

“The New GMP will fail to meet its objectives unless the government improves the distribution system including transport of drugs and storage facilities at government hospitals. At present 3-4 per cent drugs from market and 9-10 per cent from hospitals are not of standard quality. This may be due to poor logistic services. For instance, drugs from Baddi in Himachal Pradesh are transported to entire India by road or rail in normal conditions. Average temperature in India is 30-35 degrees,” says Dr Selvaraj, former director of drugs control, Tamil Nadu. “The storage facilities at government hospitals are also pathetic. All these factors lead to reduction in stability and efficacy of medications,” he added.

According to the government notification, the proposed changes in Schedule M provisions won’t apply to presently licensed manufacturers until October 31, 2020. The firms are expected to evolve methodology, systems and procedures to implement these changes that should be documented and maintained for inspection and reference. Pharmabiz