India’s Road to Independence in Manufacturing Active Pharmaceutical Ingredients: Focus on Essential Medicines

Round 1

Reviewer 1 Report

The article is a report on the current situation of the pharmaceutical industry in India. It indicates various problems, their sources and possible solutions. The article is well-written and I think that it would be interesting for a 
wide spectrum of economists (particularly in the context of the problems associated with the supply of medical goods to Europe during the current pandemic).

Author Response

We thank the reviewer for the positive comments. 

Reviewer 2 Report

The manuscript economies-1097345 here presented provides an analysis about India’s dependence on imported API’s, namely why that happens, the countries where India is more dependent on and the short and long term measures that can be put into place in order to make the country more self-sufficient in this regard.

Overall, the manuscript suffers from some weaknesses and raises concerns regarding the novelty, significance and impact in the field of economies.

A search using the keywords described in the manuscript retrieved several articles about the subject. So, in my opinion, this manuscript should bring some kind of novelty in terms of the subjects addressed or some new insights in terms of discussion in order to bring significant originality to the field. But, after reading the manuscript one realizes that the this is a summary of previously studied subjects and lacks depth in terms of discussion, thus limiting its originality.

 

Specific Comments

In general, the writing quality isn’t uniform. Parts of the document are relatively well written but in some other parts the English is poor as well as the writing, making the document difficult to read at occasions. I suggest endorsing it to a native English in order to improve this aspect.

- Graphic in figure 1 lacks a title.

- Graphic in figure 2 should have the title on top of the figure, as well as graph in figure 4. The aspect of the graphics should be harmonized between the different figures (letter size, type of letter, bars width, graph frames, etc).

Table 2: I don’t understand the reason for a table in this case. Usually in a table there is more than one column and it is possible to relate data from different places in the table. In this case (as well as tables 3 and 4) the table doesn’t seem to make sense to exist. The information in the tables can be presented as regular text using bullets.

- line 175: is it countries or country?

- Lines 317-326: the questions raised could be separated from each other using bullets.

- Lines 334-336: the authors refer some short term measures that, in my opinion, also require a substantial amount of time and effort to be put in place, and I would consider them more mid-long term measures as well.

- Table 6 could also be reformulated to become more clearly readable.

- I had some problems when trying to retrieve some references, such as the one from reuters 2020 (when I clicked in the link the page doesn’t exist).

As I read the manuscript there seems to be some overlapping of short term and long term measures. This subject is described in line 317 but the authors go back and forth between these two perspectives (short and long term) and it makes it more difficult to the reader to understand which is which. I think the authors should be more clear and concise in this matter.

In conclusion, in the present form, the manuscript does not meet strictly the requirements to be published in this journal and needs a major revision before being considered for publication.

Author Response

Comment 1: The manuscript economies-1097345 here presented provides an analysis about India’s dependence on imported API’s, namely why that happens, the countries where India is more dependent on and the short and long term measures that can be put into place in order to make the country more self-sufficient in this regard. Overall, the manuscript suffers from some weaknesses and raises concerns regarding the novelty, significance and impact in the field of economies. A search using the keywords described in the manuscript retrieved several articles about the subject. So, in my opinion, this manuscript should bring some kind of novelty in terms of the subjects addressed or some new insights in terms of discussion in order to bring significant originality to the field. But, after reading the manuscript one realizes that the this is a summary of previously studied subjects and lacks depth in terms of discussion, thus limiting its originality.

 

 

Response 1: The authors agree that there are some articles, news reports and technical documents published on this subject, most of which have been cited in this manuscript. However there is no scientific publication done in this subject using a thorough review of all the previousreports. The manuscript is written with the intention of being a comprehensive source of information of all the previous work done in this area by different stakeholders and makes recommendations to ensure pharma security.Furthermore, the authors would like to suggest that this manuscript is unique, highlighting the history of how the Indian dependence on Chinese pharmaceutical raw materials evolved, what could be the public health/ global health impact of such a dependence, and what are the likely solutions.

 

Comment 2: In general, the writing quality isn’t uniform. Parts of the document are relatively well written but in some other parts the English is poor as well as the writing, making the document difficult to read at occasions. I suggest endorsing it to a native English in order to improve this aspect.

Response 2: We have revised the language in the sections where it could be improved.

 

Comment 3: Graphic in figure 1 lacks a title.

Response 3: Figure 1 has been revised as per the suggestions of the reviewer (Page no 3). We have added the title on top of the figure.

 

(a) API production by value                (b) API production by volume

 

 

Comment 4: Graphic in figure 2 should have the title on top of the figure, as well as graph in figure 4. The aspect of the graphics should be harmonized between the different figures (letter size, type of letter, bars width, graph frames, etc).

 

Response 4: We have harmonized all the figures as per the suggestions of the reviewer. The title of figures 2 and 4 are now at the top of their respective figures (Page no 4 and 10).

 

 

Comment 5: Table 2: I don’t understand the reason for a table in this case. Usually in a table there is more than one column and it is possible to relate data from different places in the table. In this case (as well as tables 3 and 4) the table doesn’t seem to make sense to exist. The information in the tables can be presented as regular text using bullets.

 

 

Response 5: Necessary changes have been made as suggested by reviewer. The contents of the tables 2 (Page no 6 and 7), 3 (Page no 14 and 15), 4 (Page no 16) and 7 (Page no 15) have been changed to regular text with bullets. Table 7 has been merged with the earlier section line 462-465, Page no 15.  

 

 

Comment 6: line 175: is it countries or country?

 

 

Response 6: The correction has been made to ‘country’ (Line no 237; Page no 8)

 

 

Comment 7: Lines 317-326: the questions raised could be separated from each other using bullets

 

Response 7: Necessary changes have been made as reflected in lines 385-398, page no 13 and 14.

 

Comment 8: Lines 334-336: the authors refer some short term measures that, in my opinion, also require a substantial amount of time and effort to be put in place, and I would consider them more mid-long term measures as well.

 

 

Response 8: Appropriate change has been made to ensure that recommendations that may take a protracted course have been redesignated as Mid and Long term measures (Lines 605-617, Page no 19).

 

Comment 9: Table 6 could also be reformulated to become more clearly readable.

 

Response 9: Table 6 has been simplified and the text has been made more uniform with the remaining tables. (Page no 18)

 

Comment 10: I had some problems when trying to retrieve some references, such as the one from reuters 2020 (when I clicked in the link the page doesn’t exist).

 

 

Response 10: The authors rechecked the links provided to all the articles and confirm their authenticity. The reference mentioned by the reviewer ‘EU plans permanent stockpile of essential drugs, medical gear; Reuters May 28, 2020’ was checked and could be accessed by the authors.

 

Comment 11: As I read the manuscript there seems to be some overlapping of short term and long term measures. This subject is described in line 317 but the authors go back and forth between these two perspectives (short and long term) and it makes it more difficult to the reader to understand which is which. I think the authors should be more clear and concise in this matter.

 

 

Response 11: Certain conceptual duplicates among short-, mid- and long-term measures have been removed. A better assessment of the timelines required for these recommendations were done and appropriate reassignment was carried out (Lines 605-725, Page no 18-21).

Reviewer 3 Report

Please check the attachment.

Comments for author File: Comments.pdf

Author Response

Comment 1: The sections do not have a clear relationship. The consolidation of the sections would make it possible to better structure the issues at hand.

 

Response 1: The following section headings have been removed “Are pharma supply chains designed to withstand a pandemic?”, “What were the earlier steps taken to reverse API dependence” and “Suggestions for various stakeholders that emerged through the consultations” (Page no 11, 16 and 19)

 

Comment 2: The Methodology section seems inappropriate because the type of article is a review article.

 

 

Response 2: The methodology was predefined through consultation meetings with key stakeholders. It involved a thorough desk review of all existing publications, interview of key stakeholders, and identification of critical medicines. Key stakeholders for non-structured interview included government officials, industry associations, civil society organizations, policy analysts, academicians and individual pharma manufacturers.Considering the multi-faceted nature of the problem of API dependence, this methodology was recommended as a reasonable and practical means of gathering information required for the review article.

 

Comment 3: On the contrary, the inclusion of the Introduction and Conclusion sections would be appropriate.

 

 

Response 3: Appropriate changes have been made and the two relevant sections have been renamed as suggested by the reviewer (Page no 2 and 19).

 

Comment 4: Please do not use abbreviation of words and terms in the title.

 

 

Response 4: Corresponding change has been made by replacing API with pharmaceuticals (Line no 2, Page no 1)

 

Comment 5: Line 153, Line 164.

There are empty lines in the manuscript.

 

Response 5: Necessary changes have been made.

 

Comment 6: Line 207. TB. Please provide the term.

 

Response 6: Corresponding changes have been made in lines 270, 271, 288, Page no 9.

 

Comment 7: Line 356, Table 3.

There is no need to put this list of strategies in a table, it is enough to state them in the main text.

Response 7: Necessary changes have been made as suggested by Reviewer 2 & 3. The contents of the tables 2, 3 and 4 have been changed to regular text with bullets. (Lines 428-465, Page no 14, 15)

 

 

Comment 8: Line 381, Table 4.

This table also doesn't look like a table, it only contains text. Please consider structuring the information, or including it in the main text.

 

Response 8: Necessary changes have been made as suggested by Reviewer 2 & 3. The contents of the tables 2, 3 and 4 have been changed to regular text with bullets (Lines 493-527, Page no 16).

 

 

Comment 9: Line 418, Table 6.

Line 464, Table 7.
The title of the table should not be included in the table itself.

 

Response 9: Necessary changes have been made to Table 6 (which is not renumbered to Table 3) (Page no 18). Table 7 has been merged with the text as suggested by Reviewer 2 (Lines 462-465, Page no 15).

 

 

Comment 10: Line 381, Table 4.

This table also doesn't look like a table, it only contains text. Please consider structuring the information, or including it in the main text.

 

Response 10: Table 4 has been merged with the text as suggested by Reviewer 2 & 3 (Lines 493-527, Page no 16).

Round 2

Reviewer 2 Report

 

 

Author Response

The Reviewer’s comments have been very useful in improving the readability of the paper. Appropriate changes have been made to the language and spell checks have been done.

Reviewer 3 Report

The Methodology section seems inappropriate

Author Response

The Reviewer’s comments have been very useful in improving the readability of the paper. Appropriate changes have been made to the methodology section. The changes have been done from page no 4-6.