India’s FDC saga and other stories

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Framing regulations is one thing, interpreting and implementing them quite another saga, allowing repeat offenders like Biomed to remain below the radar for too long

In my last edit, (Putting the bite into our laws, http://www.expressbpd.com/pharma/editors-note/putting-the-bite-into-our-laws/40523/) I had analysed how our country’s regulations have not evolved as fast as medical technology, citing the trauma faced by patients who had undergone ASR hip implants from DePuy International, a subsidiary of Johnson & Johnson (J&J).
We then heard of the detection of traces of polio type 2 virus in some batches of oral polio vaccine (OPV) given to children as part of the government’s universal immunisation programme. The batches were traced to Ghaziabad-based pharma company Biomed, were withdrawn from circulation and the firm’s managing director was arrested.

But, Biomed seems to be a repeat offender. On March 14 this year, a notice from the DCGI informed state drug controllers that certain batches of its typhoid vaccine were found to be not of standard quality (NSQ) by the Central Drug Laboratory, Kasauli and were hence instructed to withdraw these batches.

The fact is, prevention is always better than cure. The presence of Polio Virus Type 2 strain in the vaccine, even after the central drug regulator ordered all manufacturers to destroy this strain in 2016, raises doubts on its proper destruction as well as the possible presence with other manufacturers. While it is good that the surveillance system detected this slip up, could a more stringent system, including surprise checks of manufacturers’ stocks, etc. have prevented this episode?

How many more Biomeds will it take for us to strengthen the implementation of our regulatory systems? How many more Biomeds are managing to stay below the radar? There are signs that there is a strong intent to close the loopholes. Two important draft guidelines have been released on the Central Drugs Standard Control Organization (CDSCO) website for comments from industry.

On September 25, the CDSCO released draft guidelines on Good Distribution Practices for pharma products which are open for comments for three weeks. The guidelines intend to cover not just the manufacturers, but also the staff and outlets involved in the storage and distribution of pharma products, from the premises of the manufacturer to the post of sale. Interestingly, the draft guidelines include the manufacturers of bulk, finished products, wholesalers, as well as others such as suppliers, distributors, government institutions, international procurement organisation, donor agencies and certifying bodies, logistics providers, traders, transport companies, forwarding agents and their employees as well as health workers.
Another draft guideline released on September 27 focused on guidelines for inspection of a pharmacovigilance (PV) system. It proposed a risk based programme for PV inspections of manufacturers or importers of ‘drugs’, for the collection, processing and reporting of adverse drug reactions (ADRs) to licensing authorities. This follows a meeting on September 24 where these draft guidelines were presented to and discussed with representatives of industry associations. The draft, which is open for feedback till October 31, puts the onus of reporting ADRs on manufacturers/importers. CDSCO is currently making its own assessment of the existing PV systems of companies making or importing medicinal products including pharmaceuticals, phyto-pharmaceuticals, human vaccines, blood products, rDNA technology-derived drugs and stem cell therapeutics.

Unfortunately, framing regulations is one thing, interpreting and implementing them is quite another saga, allowing repeat offenders like Biomed to remain below the radar for too long. Take the case of fixed dose combinations (FDCs). Even though the Ministry of Health & Family Welfare (MoH&FW) acted on the recommendations of the subcommittee of the Drug Technical Advisory Board (DTAB) and banned 318 FDCs, the Supreme Court of India, acting on appeals from various pharma companies, released 15 pre 1988 FDCs from the ban. The current ban impacts 0.8 per cent of the Indian pharma market (`1040 crores, as per AIOCD PharmaTrac MAT Aug 2018).

The pharma sector, like any other industry, has thus always used the law to protect its interests, often to the detriment of patients. In his article, IPRs in Trade Agreements & Access to Medicines from the CPhI Annual Industry Report 2018, Dilip Shah, Secretary General, Indian Pharmaceutical Alliance warns that such practices will only harm the image of the industry. His article analyses how the global trend towards patent term restoration and extension will result in patients needing to wait an extra 5-10 years to access generic versions of medicines. He cautions that this trend may result in consumers and governments ultimately forcing a fundamental reform of how medicines are reimbursed.

Commenting that the onus is on the pharma industry – both innovative and generic, he says, “Unfortunately, the lawyers and lobbyists are driving this agenda. It seems that Chairman and Board of Directors are not fully seized of the implications and the unintended consequences. They must wake up and question about the harm it will do to the industry’s image. No amount of PR or political donations can prevent this misfortune of own creation.” Will the pharma industry read the writing on the wall?