Shri K L Sharma, Joint Secretary (H), Ministry of Health and Family Welfare

Dear Shri Sharma,

If you recall, I met you in May 2015 after the PMO forwarded my letter to them to you for your consideration. During our meeting, you assured me that the government is taking steps to correct the systemic issues that plague the CDSCO and our regulatory process for approving medicines sold to 1.2 billion Indian citizens.

I am not sure if you have read about the recent observations made by a foreign regulator, US FDA upon inspection of a manufacturing facility of a large manufacturer of Active Pharmaceutical Ingredients located in Telangana. The observations made by the foreign inspectors thoroughly document behavior of the employees of this company which is consistent with inspection findings of almost every other large pharmaceutical manufacturer in India. CCTV records prove that the company destroyed and altered manufacturing records just prior to the inspection.

While we wait for the government to overhaul the Drugs and Cosmetics Act as you indicated to me, how do we ensure that the medicines already in the market today comply to the standards of basic quality to our citizens? I am sure you will agree that there isnt a valid reason to destroy records if everything was done by the book as many of these companies claim they do when manufacturing product for our consumption. Where Sir, is the rule of law that holds the people who indulge in such outrageous behaviour accountable to the people of this country? Isn’t destruction of records a criminal felony? If companies are so emboldened to do this for records for products sold in the US, which I am sure you will agree has a much more stringent quality expectation of their drug supply compared to what we accept in India, what do you think they are doing with the records for products they make for our patients? Do they even document what they do to manufacture products for our consumption? Does anyone care?

The CDSCO and its leadership has lost all credibility among its peers. No one takes what it says seriously anymore. Changing its name to Indian Drugs Administration does nothing to change the culture and the level of competence in our regulator. Creating a long checklist consolidating every observation made by a foreign regulator about our manufacturing facilities does not inspire confidence in our ability to understand what quality means and how to enforce standards in our manufacturing facilities. And issuing notifications to prescribers and consumers to follow label information does nothing to address the underlying problem of substandard drugs; as we have seen in the recent case of drug resistant antibiotics.

It is high time Sir, that the government did something to actually effect a meaningful change in the drug supply for the country. I realize passing legislation is not easy, and I do not envy your job. However, holding people accountable also has to be a part of the equation. When will we learn that cutting corners especially with medicine plays with lives of our citizens? Only when you hold people who do this publicly accountable. I just hope that the credibility that we, the people, have in the government to protect our drug supply doesn’t go the way of CDSCO.

Dinesh Thakur