Manufacturing quality has now become probably the single most important concern in the boardrooms of pharmaceutical companies in India. But decades of neglect cannot be reversed instantaneously and it will be some time before we start to see the results.
Ipca Laboratories was the latest to take a beating on this front. The company takes justifiable pride in its dedication to “Mission Malaria” so it was a body blow in early April when one of its most prestigious clients, the Swiss Global Fund, to which it supplied Artemisinin – based Combination Therapy (ACTs), decided to discontinue supplies from the company. The Fund cited US FDA warning letters for lapses in manufacturing norms at three of its facilities as a justification for its action.
Anti-malarials are clearly a very important part of Ipca’s product basket, which claims to be one of the world’s largest manufacturers of artemisinin-based APIs and formulations, making up 18 per cent of its turnover, according to the company website. The company leads in India’s anti-malarial market with a share of over 34 per cent and relies on supply contracts with donor organisations like UNICEF, WHO, IDA, Mission Pharma, PSI, SCMS, MSF, MEG and Ministries of Health in Africa, to expand its export footprint. The question is, will these organisations decide that they too need to follow Global Fund’s example? The impact on Ipca’s bottomline will be dismal. Its first half year results of FY16 already show some strain, with net total income down 12 per cent at Rs 1516.58 crores, exports income down 23 per cent at Rs 751.56 crores, and EBIDTA margin at 11.37 per cent as against 21.30 per cent in the previous period last year (H1 FY15). Net profit too took a beating, which at Rs 30.58 crores was down 85 per cent. The lone bright spot was that Indian formulations income was up 4 per cent at Rs 648.80 crores.
Many companies could be facing the same predicament as Ipca if they brush off 483s and warnings. This is the reason why it looks like they are finally serious about plugging the gaps in the quality systems. Our upcoming Good Manufacturing Practices (GMP) special in the May 16-31 issue will hopefully find some success stories of companies leading the pack with an extra focus on manufacturing quality.
There are some signs that India’s drug regulator is also becoming more vigilant. Though this merits analysis on a long term basis, there seems to be an increase in the number of items listed as ‘Not of Standard Quality/ Spurious/ Adulterated/ Misbranded’ in the monthly drug safety alerts released by the Central Drug Standards Control Organization (CDSCO). For instance, the alert for this March has 18 items on the list, while there were 27 in February and 25 in January. In contrast, January 2015 had 10 on the list, the following month had 17, while March last year had 14 items on the list.
The CDSCO has also moved ahead on its e-governance initiative, as part of the Prime Minister Modi’s over-arching ‘ease of business’ mission, powered by the Digital India initiative. SUGAM, CDSCO’s online portal was launched in November last year. The Import and Registration Division was the first division to accept online applications for licensing but slowly, all services are expected to move to the online mode. Will SUGAM live up to its name and provide easy access for our pharma industry? Or will it be hamstrung by infrastructure problems? The cover story in the April 16-30, 2016 issue asked this question to a cross section of the industry and got some interesting feedback. (See story, A portal for progress?’, pages 20-23)
In the same vein, on March 29, the Drug Controller General (India)’s office ordered all pending applications for clinical trials and new drugs to be cleared in three weeks. The same order also tries to ease other bottlenecks in the approval process. For instance, it clarifies that the pre-screening officer should only verify if the query has been answered, leaving the evaluation of the reply to the relevant division of the CDSCO and the Subject Matter Committee when applicable. Similarly, repeat queries on the same matter will be escalated to the DCG(I) himself during the processing of the applicant’s third reply.
The DCG(I) followed this up with another order dated April 8, stating that the status of all pending applications would be uploaded on a monthly basis on the CDSCO website and he was to be informed if any application overshot the prescribed limit. Obviously, the DCG(I) is keen to prevent any further delays in the approval process. It will take time to rebuild the trust of the industry but this seems to be a good start. For starters, the scheduled meeting on May 12 with stakeholders from the clinical trials sector will be closely watched for signals on any more changes. With regulators in all countries closing the net, defaulters will have no choice but to shape up. Or ship out.