USFDA increases inspections of drug facilities in India

USFDA  is increasing its inspections of facilities of drug makers in India, the second largest provider of finished dose products to the US, to ensure compliance of approved manufacturing norms. The US health regulator, which has been cracking the whip against many Indian pharmaceutical firms, including Ranbaxy, Wockhardt, is also recruiting and training additional drugs investigators in India. 

USFDA's presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products. Other staff include foods and devices inspectors, and policy analysts. 

In order to meet requirements of the new Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA), the US health regulator is stepping up the inspections. Under the FDASIA, the USFDA is required to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorisation period. 

India, as the second largest provider of finished dose products to the US with almost 10

per cent of that market.

Economies are faltering

A slowing down in growth rate, A record high current-account deficit. A weakening currency.  A spike in inflation.  A fall in the stock market, An increase in  job losses (right sizing or is it down sizing ) in  all most all the sectors. This is  a  phenomena happening in India”s  current economic scenario.  The economy is  worsening  day by day.

 

The same recipe that is creating India’s worst economic crisis in decades is now afflicting  few other  economies as well.   Indonesia  Consumer prices jumped 8.6 percent last month, the current-account deficit had hit  4.4 percent of Indonesian GDP.  Thailand  GDP contracted 0.3 percent in the second quarter compared with the first three months of the year. That’s the second quarterly contraction in a row for Thailand, which  confirms that Thailand is now   falling into recession.

 

A fierce selloff in many  economies ( Emerging /RDE) currencies shows no sign of abating as the expected withdrawal of US monetary stimulus prompts investors to shun markets seen as riskier because of funding deficits, slowing economies and  rising inflation. A decline in the Fed's bond purchases will push government debt yields higher, which should raise the attractiveness of the dollar and dollar-denominated assets. In many of these economies,  it has been hammered by doubts over the efficacy of policy actions to stem the rout.

In India, the rupee's sell-off threatens to drive Asia's third-largest economy towards a full-blown crisis. While the Indian government and central bank have unveiled measures ( though not enough) to support the rupee, investors are unimpressed. Bolder structural reforms, including greater fuel price liberalization, land acquisition reforms, and higher foreign investment limits in  retail, insurance,  and  few other industry are crucial to regain investor confidence and shore up the rupee else we are slowly approaching the early 1990’s.

 

The new Drug Pricing. Battle Escalates !

Several pharma  companies  & Industry bodies like Indian Drug Manufacturers Association, Confederation of Indian Pharmaceutical Industry (CIPI)  already moved  to Court  and  few more expected join, to challenge the government's new drug pricing order that asked them to slash prices of 348 medicines and also  replace stocks in the market with those carrying reduced prices within 45 days of new price notification. 

The DCPO had ordered  earlier for reduction of prices of some medicines within 45 days of issuance of the  notification and that the decreased prices be made effective on drugs already in market.The deadline for  implementation of the notification ended on July 29.

Earlier  Indian Pharmaceutical Alliance,  estimated that with the application of the new price fixation methodology on a completely new set of medicines may see the Rs 100,000-crore industry losing about Rs 2,500 crore in revenues in the near term. Market intelligence firm AIOCD-AWACS estimates that the new price control system may hit the domestic revenues of majors Ranbaxy and Cipla by 6.2 and 5.8 per cent, respectively. 

 
Prices of 348 medicines, including life saving drugs are set to be cheaper by up to 80 per cent as the new Drug Price Control Order has come into effect.